21 Regulatory Submissions jobs in Hong Kong

1 day ago Be among the first 25 applicants

This is a pivotal leadership position at the heart of our company's governance and integrity framework. As the SVP of Regulatory Compliance, you will be the designated Compliance Officer, serving as our primary liaison with the Hong Kong Monetary Authority (HKMA). You will be entrusted with the ultimate responsibility for owning, maintaining, and enhancing our compliance framework to ensure we not only meet but exceed regulatory expectations. This strategic role is critical to our license to operate, our public reputation, and our ability to innovate responsibly.

Key Responsibilities:

• Regulatory Relationship Management:
• Lead and manage all regulatory engagement with the HKMA and other relevant authorities. Act as the primary, official point of contact for supervisory teams, handling inquiries, coordinating examinations, and ensuring timely, accurate, and high-quality responses.
• Cultivate and maintain a relationship of trust and transparency with our regulators.
• Compliance Framework & Governance:
• Own and continuously enhance the company's compliance framework, including all policies, procedures, and internal controls to ensure robust adherence to all applicable laws, particularly the Payment Systems and Stored Value Facilities Ordinance (PSSVFO) and other relevant guidelines and circulars.
• Proactively oversee the regulatory monitoring process to identify, assess, and implement necessary changes in response to the evolving legal and regulatory landscape.
• Leadership & Culture:
• Drive a strong, proactive compliance culture throughout the entire organization, from the board level to daily operations.
• Develop and deliver impactful, ongoing compliance training programs for all staff to ensure a high level of awareness and competence across the company.
• Serve as a key member of the leadership team, providing guidance and strategic input on all matters with regulatory implications.
• Advisory & Assurance:
• Act as a strategic advisor to the business and senior management, providing pragmatic and commercially-minded compliance guidance on new products, business initiatives, and emerging technologies.
• Lead internal compliance reviews and risk assessments to provide assurance to the Board and senior management on the effectiveness of the control environment.
• Designated Officer Roles:
• Formally act as the designated Compliance Officer and Code of Conduct Officer for the company, maintaining all required regulatory records and fulfilling all statutory obligations associated with these roles.

Qualifications & Experience:

• A minimum of 10 years of progressive experience in regulatory compliance, risk management, or internal audit within an HKMA-regulated Authorized Institution (AI), Stored Value Facility (SVF), or a relevant regulatory body.
• Deep, demonstrable expertise in the Hong Kong regulatory environment, particularly the Banking Ordinance, PSSVFO and the HKMA's AML/CFT guidelines. Direct experience with Banking or SVF regulations is strongly preferred.
• Bachelor's degree in Law, Finance, Accounting, or a related discipline. Relevant professional qualifications are highly advantageous.
• Proven track record of successfully managing relationships and communications with financial regulators, especially the HKMA.
• Exceptional communication, interpersonal, and stakeholder management skills, with the gravitas to engage effectively with senior management, the Board of Directors, and regulators.
• A proactive, hands-on, and commercially-minded leader with unwavering integrity and a commitment to upholding the highest ethical standards.

General Culture and Benefits of RD Technologies

• Exciting and collaborative startup environment.
• Give your best while having fun and grow as a person.
• A flat structure: your ideas get heard by the right people very quickly.
• Creating your own profile in the startup ecosystem.
• Casual dress code.
• Free coffee, tea, drinks and snacks daily.
• In-house gym facilities.
• Regular and fun company activities.
• Other leaves in addition to annual leaves, e.g. marriage leave, birthday leave, compassionate leave.

Data collected would be used for recruitment purposes only. Applicants who do not hear from us may consider their application unsuccessful and their data will be destroyed within 24 months of receipt.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Business Development and Sales

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Manager, Regulatory Compliance & Advisory Manager, Regulatory Compliance & Advisory

3 days ago Be among the first 25 applicants

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Prudential’s purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support our people’s career ambitions. We pledge to make Prudential a place where you can Connect, Grow, and Succeed.

To support the Director, Advisory & Regulatory Compliance in discharging his duties and ensure compliance with relevant law, regulations and Group policies. Providing advice on products and marketing campaign/promotions, liaison for product and marketing materials’ approval by Compliance, as well as providing advisory support for Product and Marketing teams. The role will also provide support on projects and new business initiatives as well as regulatory change implementation, as well as administrative support to the Compliance Advisory team.

Job Responsibilities

• Conduct independent product compliance review throughout the product development cycle as well as post-sales monitoring, including but not limited to ensure the product design meets all applicable regulatory requirements and “Treat Customer Fairly” principle, review the relevant sales and marketing materials as well as the training materials; (iii) product promotion campaign; (iv) marketing campaign, etc.
• Provide advice on product and marketing initiatives
• Provide support on projects and new business initiatives and coordination for regulatory change implementation as and when required
• Provide administrative support in the maintenance of Regulatory Matrix and the Regulatory Compliance System
  
  
  

Job Requirements

• Degree holder in related disciplines
• Have over 8 years working experience with at least 5 years in product compliance area in life insurance industry
• Excellent knowledge of (i) laws and regulatory requirements applicable to Life insurance products, and (ii) Life insurance operations (including life administration and agency administration), e.g. underwriting, policy administration, claims, and sales channels (covering agency, bancassurance and broker channels)
• Demonstrate ability on adoption of agile way of working, flexible to change, and ability to make independent, sound and informed decisions
• Excellent command of English and Chinese (written and spoken)
  
  
  

Prudential is an equal opportunity employer. We provide equality of opportunity of benefits for all who apply and who perform work for our organisation irrespective of sex, race, age, ethnic origin, educational, social and cultural background, marital status, pregnancy and maternity, religion or belief, disability or part-time / fixed-term work, or any other status protected by applicable law. We encourage the same standards from our recruitment and third-party suppliers taking into account the context of grade, job and location. We also allow for reasonable adjustments to support people with individual physical or mental health requirements.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Finance and Sales

Referrals increase your chances of interviewing at Prudential Hong Kong by 2x

Get notified about new Regulatory Compliance Manager jobs in Hong Kong, Hong Kong SAR .

Senior Regulatory Compliance Manager (Private Banking) Senior Manager, Global Compliance & Ethics (Bangkok Based, Relocation Provided) Senior Compliance Manager-Consumer Protection FSO - Risk Consulting - NFR (Regulatory Compliance) - Manager or above - HK (Senior) Business Compliance Manager (Corporate Business Compliance Division) Senior Manager, FinCrime Compliance (Bangkok Based, Relocation Provided) Compliance Manager / Senior Manager - Life Insurer Senior Manager & Team Head / Senior Manager – Business & Compliance Department under eMPF Company Assistant Manager – Facilities Management and Projects (13-month Contract) Distribution Operation & Administration, Specialist (Asst Manager Level) Senior Technology Risk Manager (Overseas Branch) Senior Manager – Leasing & Tenancy Compliance Technology Risk Management – Manager (Overseas Branch)

Hong Kong, Hong Kong SAR
$36,000.00
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$70,000.00
3 weeks ago

Assistant Manager/ Manager – Regulatory & Compliance Senior Officer, Corporate Governance (Ref: CIA188/25, 10508) HEAD OF COMPLIANCE | REGIONAL BANK | INTERNATIONAL EXPANSION (Assistant / Deputy) Compliance Manager (Compliance Review)

Central & Western District, Hong Kong SAR 4 weeks ago

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Manager, Regulatory Compliance & Advisory Manager, Regulatory Compliance & Advisory

3 days ago Be among the first 25 applicants

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Prudential’s purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support our people’s career ambitions. We pledge to make Prudential a place where you can Connect, Grow, and Succeed.
To support the Director, Advisory & Regulatory Compliance in discharging his duties and ensure compliance with relevant law, regulations and Group policies. Providing advice on products and marketing campaign/promotions, liaison for product and marketing materials’ approval by Compliance, as well as providing advisory support for Product and Marketing teams. The role will also provide support on projects and new business initiatives as well as regulatory change implementation, as well as administrative support to the Compliance Advisory team.
Job Responsibilities

• Conduct independent product compliance review throughout the product development cycle as well as post-sales monitoring, including but not limited to ensure the product design meets all applicable regulatory requirements and “Treat Customer Fairly” principle, review the relevant sales and marketing materials as well as the training materials; (iii) product promotion campaign; (iv) marketing campaign, etc.
• Provide advice on product and marketing initiatives
• Provide support on projects and new business initiatives and coordination for regulatory change implementation as and when required
• Provide administrative support in the maintenance of Regulatory Matrix and the Regulatory Compliance System
  

Job Requirements

• Degree holder in related disciplines
• Have over 8 years working experience with at least 5 years in product compliance area in life insurance industry
• Excellent knowledge of (i) laws and regulatory requirements applicable to Life insurance products, and (ii) Life insurance operations (including life administration and agency administration), e.g. underwriting, policy administration, claims, and sales channels (covering agency, bancassurance and broker channels)
• Demonstrate ability on adoption of agile way of working, flexible to change, and ability to make independent, sound and informed decisions
• Excellent command of English and Chinese (written and spoken)
  

Prudential is an equal opportunity employer. We provide equality of opportunity of benefits for all who apply and who perform work for our organisation irrespective of sex, race, age, ethnic origin, educational, social and cultural background, marital status, pregnancy and maternity, religion or belief, disability or part-time / fixed-term work, or any other status protected by applicable law. We encourage the same standards from our recruitment and third-party suppliers taking into account the context of grade, job and location. We also allow for reasonable adjustments to support people with individual physical or mental health requirements. Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Finance and Sales

Referrals increase your chances of interviewing at Prudential Hong Kong by 2x

Get notified about new Regulatory Compliance Manager jobs in Hong Kong, Hong Kong SAR .

Senior Regulatory Compliance Manager (Private Banking) Senior Manager, Global Compliance & Ethics (Bangkok Based, Relocation Provided) Senior Compliance Manager-Consumer Protection FSO - Risk Consulting - NFR (Regulatory Compliance) - Manager or above - HK (Senior) Business Compliance Manager (Corporate Business Compliance Division) Senior Manager, FinCrime Compliance (Bangkok Based, Relocation Provided) Compliance Manager / Senior Manager - Life Insurer Senior Manager & Team Head / Senior Manager – Business & Compliance Department under eMPF Company Assistant Manager – Facilities Management and Projects (13-month Contract) Distribution Operation & Administration, Specialist (Asst Manager Level) Senior Technology Risk Manager (Overseas Branch) Senior Manager – Leasing & Tenancy Compliance Technology Risk Management – Manager (Overseas Branch)

Hong Kong, Hong Kong SAR
$36,000.00
-
$70,000.00
3 weeks ago

Assistant Manager/ Manager – Regulatory & Compliance Senior Officer, Corporate Governance (Ref: CIA188/25, 10508) HEAD OF COMPLIANCE | REGIONAL BANK | INTERNATIONAL EXPANSION (Assistant / Deputy) Compliance Manager (Compliance Review)

Central & Western District, Hong Kong SAR 4 weeks ago

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**Director, Regulatory, Product and Sales Compliance**
The Director of Regulatory, Product and Sales Compliance will play an essential role in ensuring the organization's adherence to regulatory standards and internal compliance frameworks. This position requires good knowledge in compliance matters related to product governance, sales practices and marketing material reviews. Key responsibilities include:
**Position Responsibilities:**
+ Providing compliance advisory support for the Regulatory, Product and Sales Compliance team, with a focus on product development, sales processes and marketing materials review;
+ Assisting in the design and implementation of effective compliance programs that address regulatory requirements and internal control frameworks across product, sales and operational functions;
+ Reviewing and advising on new business initiatives, regulatory developments, marketing strategies and emerging compliance risks;
+ Partnering with business units to develop and embed effective control mechanisms and regulatory processes, including customer due diligence, risk identification, product and sales governance;
+ Conducting thorough reviews and providing compliance clearance on product materials, sales campaigns and associated marketing materials;
+ Reviewing periodic compliance and regulatory reports and support annual corporate compliance reporting exercises
**Required Qualifications:**
+ Degree holder in Law, Accounting or Finance;
+ At least 8 years of relevant compliance experience with 5 years in the insurance or asset management industry preferred;
+ Proven experience in engaging with regulatory bodies such as the Insurance Authority and Securities and Futures Commission
+ Good command of both written and spoken English and Chinese
+ Strong analytical and problem-solving skills
+ Demonstrated ability to work independently, with a proactive and detail-oriented approach
+ In-depth knowledge of compliance practices in the life insurance sector, experience with ILAS products an advantage
**When you join our team:**
+ We'll empower you to learn and grow the career you want.
+ We'll recognize and support you in a flexible environment where well-being and inclusion are more than just words.
+ As part of our global team, we'll support you in shaping the future you want to see.
**Acerca de Manulife y John Hancock**
Manulife Financial Corporation es un importante proveedor internacional de servicios financieros que ayuda a las personas a tomar decisiones de una manera más fácil y a vivir mejor. Para obtener más información acerca de nosotros, visite .
**Manulife es un empleador que ofrece igualdad de oportunidades**
En Manulife/John Hancock, valoramos nuestra diversidad. Nos esforzamos por atraer, formar y retener una fuerza laboral tan diversa como los clientes a los que prestamos servicios, y para fomentar un entorno laboral inclusivo en el que se aprovechen las fortalezas de las culturas y las personas. Estamos comprometidos con la equidad en las contrataciones, la retención de talento, el ascenso y la remuneración, y administramos todas nuestras prácticas y programas sin discriminación por motivos de raza, ascendencia, lugar de origen, color, origen étnico, ciudadanía, religión o creencias religiosas, credo, sexo (incluyendo el embarazo y las afecciones relacionadas con este), orientación sexual, características genéticas, condición de veterano, identidad de género, expresión de género, edad, estado civil, estatus familiar, discapacidad, o cualquier otro aspecto protegido por la ley vigente.
Nuestra prioridad es eliminar las barreras para garantizar la igualdad de acceso al empleo. Un representante de Recursos Humanos trabajará con los solicitantes que requieran una adaptación razonable durante el proceso de solicitud. Toda la información que se haya compartido durante el proceso de solicitud de adaptación se almacenará y utilizará de manera congruente con las leyes y las políticas de Manulife/John Hancock correspondientes. Para solicitar una adaptación razonable en el proceso de solicitud, envíenos un mensaje a .
**Modalidades de Trabajo**
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Join to apply for the Senior Regulatory Affairs Specialist role at Teva Pharmaceuticals

2 days ago Be among the first 25 applicants

Join to apply for the Senior Regulatory Affairs Specialist role at Teva Pharmaceuticals

Get AI-powered advice on this job and more exclusive features.

Who We Are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

Who We Are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

A full-time position for Hong Kong to work on new submission / maintenance / labelling / regulatory compliance.

Collaborate with Quality, Supply Chain and Commercial Team.

Involvement in multinational regulatory issues and with concepts of regulatory strategy.

Ensure that all new products are registered according to local authority regulations and corporate policy as well as maintaining the MA of the existing products.

Ensure labeling (including local repackaging components) of all products introduced in the local market are compliant to local regulatory requirements and Corporate Guidelines.

Ensure that all changes in particulars and renewal of registered products as required by the local Health Authorities which are in compliance with corporate policy and the local Authorities’ regulations.

Collaborating with local partners in Macau comply with regulations on medicinal products.

How You’ll Spend Your Day

New Product / Project Registration:

• Coordinate and support technical and scientific regulatory activities
• Communication with oversea counterpart for necessary dossiers and documents for submissions
• Work with global RA and business partners of updating submission progress
  
  

Lifecycle Management

• Plan and manage product lifecycle changes
• Coordinate and monitor artwork / packaging process of variation of existing products
• Review and update Patient Information Leaflet in accordance with local regulatory requirements / company guideline
  
  

Business Support

• Provide regulatory support for commercial activities, e.g. registration information for tender submission
• Review of marketing materials. Ensure promotional materials are complied with the requirements of Undesirable Medical Advertisement Ordinance (UMAO) and DoH registration guidelines
  
  

RA Processes

• Ensure that processes are clearly defined in SOPs for all critical tasks/duties e.g. regulatory filings, artwork, etc.
• Establish and review local SOP/WIs
• Maintain good record, databases, data of product registration and licenses per company guideline
  
  

Your Experience And Qualifications

• Basic Degree in Life Sciences specialties, e.g. Pharmacy, Medicine, Biological Sciences
• Preferably 2 or more years of regulatory experience in pharma and regulated industry
• Experience in registration of medicinal products
• Flexibility to work in a cross-cultural environment
• Basic knowledge in drug development, pharmacovigilance, GxP processes, QA would be advantageous
• A good balance of Regulatory and Business acumen
• Solid knowledge and understanding of local drug / healthcare regulations and ability to apply them at work effectively
• Good communication skills, fluent in written and spoken English in additional to local language to interact effectively with the government agencies in the country
• Able to work under pressure and to tight timelines
• Effective time management and multi-tasking
• Flexibility in working schedule
• Spontaneous team player and collaborator
• Flair to simplify complex issues and manage project efficiently
• Attention to details and logical analytical skills
• Computer literacy
• Demonstrated ability to handle competing priorities effectively
• Results oriented, business-oriented and self-motivating
• Openness to change and ability to think out of the box
  
  

Make a difference with Teva Pharmaceuticals

Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role.

Please note that only shortlisted candidates will be contacted.

Reports To

Head of Regulatory Affairs, Hong Kong & Taiwan

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Legal
• Industries Wellness and Fitness Services, Biotechnology Research, and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Teva Pharmaceuticals by 2x

Get notified about new Senior Regulatory Affairs Specialist jobs in Hong Kong SAR .

Consultant/Senior Consultant - Risk & Regulatory Compliance (SFC) REGULATORY AFFAIRS MANAGER / RA MANAGER – medical device manufacturer (Kwai Fong/5 days) Senior Consultant - Regulatory & Financial Risk - Hong Kong(314327) Senior Manager Wholesale Regulatory Affairs and Credit Policy - Risk and Compliance Regulatory Affairs Specialist (Fresh Grad is welcomed)

Hong Kong, Hong Kong SAR HK$18,000.00-HK$20,000.00 5 days ago

Regulatory Affairs Specialist, Asia Pacific Region

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at .

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mongkok, Kowloon, Hong Kong

Job Description:

1. Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
2. Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
3. Applies in-depth knowledge on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
4. Identifies opportunities for input on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
5. Completes detailed regulatory submissions required for new and existing product approvals and registrations.
6. Communicates Regulatory Affairs interpretation and feedback in support of federal, state, and international regulations by preparing documentation and reports to support internal and external audits.
7. Coaches more junior colleagues in techniques, processes, and responsibilities.
8. Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with the team.

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Senior Regulatory Affairs Specialist
Date: Aug 4, 2025
Location:
Mongkok, Hong Kong, 122001
Company: Teva Pharmaceuticals
Job Id: 63197
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
A full-time position for Hong Kong to work on new submission / maintenance / labelling / regulatory compliance.
Collaborate with Quality, Supply Chain and Commercial Team.
Involvement in multinational regulatory issues and with concepts of regulatory strategy.
Ensure that all new products are registered according to local authority regulations and corporate policy as well as maintaining the MA of the existing products.
Ensure labeling (including local repackaging components) of all products introduced in the local market are compliant to local regulatory requirements and Corporate Guidelines.
Ensure that all changes in particulars and renewal of registered products as required by the local Health Authorities which are in compliance with corporate policy and the local Authorities' regulations.
Collaborating with local partners in Macau comply with regulations on medicinal products.
**How you'll spend your day**
New Product / Project Registration:
+ Coordinate and support technical and scientific regulatory activities
+ Communication with oversea counterpart for necessary dossiers and documents for submissions
+ Work with global RA and business partners of updating submission progress
Lifecycle Management:
+ Plan and manage product lifecycle changes
+ Coordinate and monitor artwork / packaging process of variation of existing products
+ Review and update Patient Information Leaflet in accordance with local regulatory requirements / company guideline
Business Support:
+ Provide regulatory support for commercial activities, e.g. registration information for tender submission
+ Review of marketing materials. Ensure promotional materials are complied with the requirements of Undesirable Medical Advertisement Ordinance (UMAO) and DoH registration guidelines
RA Processes:
+ Ensure that processes are clearly defined in SOPs for all critical tasks/duties e.g. regulatory filings, artwork, etc.
+ Establish and review local SOP/WIs
+ Maintain good record, databases, data of product registration and licenses per company guideline
**Your experience and qualifications**
+ Basic Degree in Life Sciences specialties, e.g. Pharmacy, Medicine, Biological Sciences
+ Preferably 2 or more years of regulatory experience in pharma and regulated industry
+ Experience in registration of medicinal products
+ Flexibility to work in a cross-cultural environment
+ Basic knowledge in drug development, pharmacovigilance, GxP processes, QA would be advantageous
+ A good balance of Regulatory and Business acumen
+ Solid knowledge and understanding of local drug / healthcare regulations and ability to apply them at work effectively
+ Good communication skills, fluent in written and spoken English in additional to local language to interact effectively with the government agencies in the country
+ Able to work under pressure and to tight timelines
+ Effective time management and multi-tasking
+ Flexibility in working schedule
+ Spontaneous team player and collaborator
+ Flair to simplify complex issues and manage project efficiently
+ Attention to details and logical analytical skills
+ Computer literacy
+ Demonstrated ability to handle competing priorities effectively
+ Results oriented, business-oriented and self-motivating
+ Openness to change and ability to think out of the box
**Make a difference with Teva Pharmaceuticals**
Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role.
Please note that only shortlisted candidates will be contacted.
**Reports To**
Head of Regulatory Affairs, Hong Kong & Taiwan
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mongkok, Kowloon, Hong Kong

Job Description:

• Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
• Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
• Applies in-depth knowledge on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
• Identifies opportunities for input on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
• Completes detailed regulatory submissions required for new and existing product approvals and registrations.
• Communicates Regulatory Affairs interpretation and feedback in support of federal, state, and international regulations by preparing documentation and reports to support internal and external audits.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with the team.

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Who We Are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

Who We Are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
A full-time position for Hong Kong to work on new submission / maintenance / labelling / regulatory compliance.
Collaborate with Quality, Supply Chain and Commercial Team.
Involvement in multinational regulatory issues and with concepts of regulatory strategy.
Ensure that all new products are registered according to local authority regulations and corporate policy as well as maintaining the MA of the existing products.
Ensure labeling (including local repackaging components) of all products introduced in the local market are compliant to local regulatory requirements and Corporate Guidelines.
Ensure that all changes in particulars and renewal of registered products as required by the local Health Authorities which are in compliance with corporate policy and the local Authorities’ regulations.
Collaborating with local partners in Macau comply with regulations on medicinal products.
How You’ll Spend Your Day
New Product / Project Registration:

• Coordinate and support technical and scientific regulatory activities
• Communication with oversea counterpart for necessary dossiers and documents for submissions
• Work with global RA and business partners of updating submission progress
  

Lifecycle Management

• Plan and manage product lifecycle changes
• Coordinate and monitor artwork / packaging process of variation of existing products
• Review and update Patient Information Leaflet in accordance with local regulatory requirements / company guideline
  

Business Support

• Provide regulatory support for commercial activities, e.g. registration information for tender submission
• Review of marketing materials. Ensure promotional materials are complied with the requirements of Undesirable Medical Advertisement Ordinance (UMAO) and DoH registration guidelines
  

RA Processes

• Ensure that processes are clearly defined in SOPs for all critical tasks/duties e.g. regulatory filings, artwork, etc.
• Establish and review local SOP/WIs
• Maintain good record, databases, data of product registration and licenses per company guideline
  

Your Experience And Qualifications

• Basic Degree in Life Sciences specialties, e.g. Pharmacy, Medicine, Biological Sciences
• Preferably 2 or more years of regulatory experience in pharma and regulated industry
• Experience in registration of medicinal products
• Flexibility to work in a cross-cultural environment
• Basic knowledge in drug development, pharmacovigilance, GxP processes, QA would be advantageous
• A good balance of Regulatory and Business acumen
• Solid knowledge and understanding of local drug / healthcare regulations and ability to apply them at work effectively
• Good communication skills, fluent in written and spoken English in additional to local language to interact effectively with the government agencies in the country
• Able to work under pressure and to tight timelines
• Effective time management and multi-tasking
• Flexibility in working schedule
• Spontaneous team player and collaborator
• Flair to simplify complex issues and manage project efficiently
• Attention to details and logical analytical skills
• Computer literacy
• Demonstrated ability to handle competing priorities effectively
• Results oriented, business-oriented and self-motivating
• Openness to change and ability to think out of the box
  

Make a difference with Teva Pharmaceuticals
Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role.
Please note that only shortlisted candidates will be contacted.
Reports To
Head of Regulatory Affairs, Hong Kong & Taiwan
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Legal
• Industries Wellness and Fitness Services, Biotechnology Research, and Pharmaceutical Manufacturing

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