What Jobs are available for Regulatory Affairs Specialist in Hong Kong?
Showing 69 Regulatory Affairs Specialist jobs in Hong Kong
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Roche Diagnostics
*Main Responsibilities: *
- Managing local regulatory plan in cooperation with other internal stakeholders to ensure our products are registered on timely manner and business objectives are met
- Submitting technical documentation to Regulatory Authorities and securing registration approval in a timely manner
- Maintaining product registration throughout a product's lifecycle by applying appropriate regulatory change control
- Providing Global RA with real-time information required to maintain key metrics (i.e. submission dates and approval dates for all product registrations)
- Monitoring and communicating new, upcoming & changes to regulations with local stakeholders and Global RA
- Influencing / shaping regulatory landscape/regulations where possible ("advocacy")
*Requirements: *
- A minimum of a B.S. degree in biomedical science, life science or related field, with 2-3 years health-related quality-focused and regulatory experience
- Knowledge of diagnostics is preferable
- Strong interpersonal communication skills
- Self-starter, highly motivated with attention to details
- Excellent command of written and spoken English and Chinese
- Must be able to work independently, by taking general concepts and direction to produce desirable compliant outcomes
- Ability to prioritize multiple tasks and to function effectively
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer.
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Senior Specialist, Regulatory Affairs
Posted today
Job Viewed
Job Description
Recruit Ref: L
Posting Date:
Teva
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.
Senior Specialist, Regulatory Affairs
Description:
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.
Profile:
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
Offer:
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
Please click:
Industry:
Pharmaceutical Products & Cosmetics
Job Category / Function:
Others (Others)
Hospital / Medical / Pharmaceutical (Others)
Job Position Level:
Senior
Employment Term:
-
Min. Edu. Level Req:
Bachelor
Minimum QF Level attained:
-
Total Working Exp:
2 or above
Salary(HKD):
- (Monthly)
Benefits:
-
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Senior Specialist Regulatory Affairs
Posted today
Job Viewed
Job Description
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, 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.
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Senior Specialist, Regulatory Affairs
Posted 28 days ago
Job Viewed
Job Description
Date: Oct 1, 2025
Location:
Tsim Sha Tsui, Hong Kong,
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
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Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
Bank of Singapore opens doors to new opportunities.
At Bank of Singapore, we are constantly on the lookout for exceptional individuals to join our team. We promote a culture of openness, teamwork and fairness. Most importantly, we invest in our people through our programmes that develop them on both professional and personal levels. Besides attractive remuneration packages, we offer non-financial benefits and opportunities to develop your potential within OCBC Group's global network of subsidiaries and offices. If you have passion, drive and the will to succeed, rise to the challenge today
Main Duties
- Handle staff dealing issues including preparation of consent letter sent to securities brokers of staff, in particular with expected increase in front office. This task is important in accordance with HK SFC Code of Conduct requirements
- Provide compliance briefing to new joiners so as to ensure new joiners adapt to BOS and regulatory requirements as well as bank culture
- Handle staff registration of licensed staff with HKMA so that front office can carry out regulated activities and account opening asap
- Handle various staff declarations such as external business and shareholding declarations, staff annual declaration checking and filing so that potential conflict of interests can be properly monitored in accordance with Group's and regulatory standards
- Review and approve Continuous Professional Training/Ongoing Professional Training hours for front office in order to maintain their licenses with HKMA/SFC
- Provide support to handle company secretarial tasks (e.g. filing of change of BOS directors and their particulars to HK SFC and Companies Registrars etc) of BOS HK
- Provide regulatory compliance advice and support to management and staff of HK Branch
- Provide support to the existing general compliance and product compliance sub teams
- Assist in completing regulatory submission, surveys, offsite reviews and ad hoc requests (both HKMA and SFC)
- Assist in providing regulatory compliance related support in GA audit
- Provide all necessary support to head office RC when needed
Competence Requirements
- Minimum of 3-5 years' industry experience
- Holds a bachelor's degree, or equivalent
- Private bank or brokerage experience from advisory is desired
- Has the ability to work well within a matrix organization
- The ability to drill down to root cause, develop solutions, and lead process change
- Preferable for candidates with HKIB Enhanced Competency Framework (ECF) professional qualification
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Regulatory Compliance
Posted today
Job Viewed
Job Description
Responsibilities
- Support the regulatory compliance function covering licensing and the regulated activities including the investment and insurance distribution activities and asset management
- Keep track of regulatory updates, establish and maintain regulatory register and identify gaps
- Assist to formulate the compliance program and conduct the compliance review
- Prepare compliance training materials
- Assist in end-to-end investigation on Clients' Complaints and self-escalated misconduct including the investigation report
- Assist in other compliance related tasks as assigned
Qualifications
- University degree
- At least 2 years or relevant experience in SFC licensed corporation
- Familiar with the SFC rules and regulations and industry practices
- Strong interpersonal and communication skills, self-motivated, responsible and fast paced work under pressure and meet tight deadlines
- Fluent in Mandarin, English and Cantonese
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Regulatory Compliance
Posted today
Job Viewed
Job Description
Responsibilities
- Support the regulatory compliance function covering licensing and the regulated activities including the investment and insurance distribution activities and asset management
- Keep track of regulatory updates, establish and maintain regulatory register and identify gaps
- Assist to formulate the compliance program and conduct the compliance review
- Prepare compliance training materials
- Assist in end-to-end investigation on Clients' Complaints and self-escalated misconduct including the investigation report
- Assist in other compliance related tasks as assigned
Qualifications
- University degree
- At least 2 years or relevant experience in SFC licensed corporation
- Familiar with the SFC rules and regulations and industry practices
- Strong interpersonal and communication skills, self-motivated, responsible and fast paced work under pressure and meet tight deadlines
- Fluent in Mandarin, English and Cantonese
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Regulatory compliance VP
Posted today
Job Viewed
Job Description
Lead regulatory compliance at a fast-growing fintech with regional licensing across Asia.
Your new company
This opportunity is with a fast-growing fintech firm headquartered in Asia, offering innovative payment and financial solutions to businesses across the region. The company is expanding its footprint and has obtained key regulatory approvals, including licensing for virtual asset trading and payment services. With a strong focus on compliance and governance, the organization is committed to building a secure and transparent financial ecosystem.
Your new role
As the Regulatory Compliance VP, you will:
- Oversee regulatory compliance across multiple jurisdictions, including Hong Kong and Singapore.
- Manage licensing processes and regulatory relationships, particularly with SFC and VATP-related frameworks.
- Develop and maintain internal compliance policies and procedures aligned with evolving regulatory requirements.
- Lead internal audits, gap analyses, and remediation efforts.
- Support product development and business expansion from a compliance perspective.
What you'll need to succeed
- Proven experience in regulatory compliance within fintech, virtual asset platforms, or licensed financial institutions.
- Strong understanding of SFC licensing, VATP regulations, and regional compliance frameworks.
- Familiarity with AML, KYC, and financial crime prevention standards.
- Excellent communication and stakeholder management skills.
- Fluency in English; Cantonese or Mandarin is a plus.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or share your profile to
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
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Manager, Regulatory Compliance
Posted today
Job Viewed
Job Description
Our client is seeking a highly motivated and experienced professional in the Regulatory Compliance and Inspection function. This role is ideal for someone with a strong compliance background, particularly in the securities or brokerage industry, and hands-on experience in enforcement, inspections, and trading rules. The successful candidate will be responsible for ensuring regulatory adherence, managing inspections, and promoting a culture of ethical conduct and compliance through training and market education.
Key Responsibilities
- Lead the development, implementation, and oversight of the company's compliance and market conduct framework.
- Ensure full compliance with all applicable laws, regulations, and internal policies, particularly those governing the secondary market.
- Conduct inspections and compliance risk assessments and manage regulatory inquiries and enforcement-related matters.
- Oversee and enforce rules related to trading activities, ensuring alignment with market conduct standards.
- Act as the primary liaison with regulatory bodies, handling inspections and regulatory reviews.
- Provide expert guidance to business units on compliance issues and regulatory developments.
- Handle compliance cases independently, from investigation to resolution.
- Monitor and report on compliance breaches, recommending and tracking corrective actions.
Qualifications and Skills
- Must be CPA certified.
- Minimum of 3 – 5 years of experience in compliance, audit, or regulatory roles, preferably within the securities or brokerage industry.
- Solid understanding of regulatory frameworks, market conduct standards, and secondary market enforcement.
- Experience in HKEX, SCO, SFC guidelines.
- Proven experience in handling inspections, case management, and trading rules enforcement.
- Hands-on experience in data analysis using Tableau or similar visualization platforms.
- Strong communication skills in Cantonese, English, and Mandarin
Please visit Adecco website with the below link for application:
Please note that only shortlisted candidates will be notified. All information gathered will be treated in strictly confidential and solely used for recruitment purpose.
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Manager, Regulatory Compliance
Posted today
Job Viewed
Job Description
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 is a must
- 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.
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