34 Policy Enforcement jobs in Hong Kong

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.

#J-18808-Ljbffr

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

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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

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

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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3 days ago Be among the first 25 applicants

For over 15 years, Camber Pharmaceuticals has been one of the fastest-growing generics companies in the United States. Since its inception, Camber has shown a tradition of excellence and a deep commitment to providing cost-effective processes to treat a wide range of therapeutic categories.

Through our parent company, Hetero ( Camber is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development, and commercialization. Hetero is India’s largest privately held pharmaceutical company and a world leader in API production, with a strong global presence in over 126 countries.

Saving lives is our passion, and we continue to help shape a healthier world through affordable medications.

About the Role

We are seeking an experienced Regulatory Affairs Manager with expertise in drug registration, dossier submissions, and HA (Hospital Authority) tendering processes in Hong Kong. In this role, you will ensure compliance with local regulatory requirements, manage submissions to the Department of Health (DH), and support tender applications for public hospital listings.

This is a great opportunity for a detail-oriented regulatory professional who thrives in a fast-paced environment and enjoys working closely with cross-functional teams to bring pharmaceutical products to market.

Key Responsibilities

• Prepare, review, and submit drug registration dossiers (CTD/eCTD format) to the Hong Kong Department of Health (DH) and other regulatory bodies.
• Monitor and interpret evolving regulatory requirements for pharmaceuticals in Hong Kong.
• Manage the HA tendering process, including preparation of tender documents, compliance checks, and post-submission follow-ups.
• Liaise with health authorities, internal stakeholders, and third-party vendors** to ensure smooth regulatory approvals.
• Conduct gap analyses for existing and new product registrations to ensure compliance.
• Maintain up-to-date knowledge of ICH, ASEAN, and local regulatory guidelines.
• Support post-approval variations, renewals, and labeling updates** as needed.
• Collaborate with Quality Assurance, Pharmacovigilance, and Commercial teams to align regulatory strategies.

Qualifications & Experience

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related field.
• 4+ years of hands-on experience in Drug registration & dossier submissions in Hong Kong (CTD/eCTD), HA tendering process (public hospital procurement submissions) .
• Knowledge in regulatory compliance for pharmaceuticals (HK DH, PMDA, FDA, or EMA experience a plus).
• Strong analytical skills with the ability to interpret complex regulatory guidelines.
• Excellent communication skills (written & verbal) in English and Cantonese (Mandarin a plus).
• Proactive, detail-oriented, and able to manage multiple deadlines.
• Experience working with CROs, regulatory agencies, or pharmaceutical companies preferred.

Why Join Us?

MPF + Medical insurance coverage.

18 days annual leave

Opportunity to work on diverse regulatory projects in a dynamic team.

If you are a Regulatory Affairs professional with expertise in drug registration and HA tenders, we would love to hear from you! Apply now or share this opportunity with your network.

#RegulatoryAffairs #PharmaJobs #HongKongJobs #DrugRegistration #HATendering #LinkedInJobs #Hiring

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Legal
• Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Camber Pharmaceuticals Inc by 2x

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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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

Orka is an innovative VC-backed startup dedicated to revolutionizing the hearing aid market with our groundbreaking products and services. Our mission is to improve lives by developing exceptional hearing aids that cater to individual needs while incorporating cutting-edge technology, to transform people's hearing journey from chaos to simplicity. As we continue to expand, we are looking for an exceptional RA&QA expert to join our growing team.

The Role

As the Head of Regulatory Affaris & Quality Assurance at our medical device company, you will be responsible for leading the Regulatory Affairs and Quality Assurance functions. Your role is critical in ensuring compliance with regulatory standards, maintaining quality control processes, and driving the company's adherence to industry regulations. You will play a key role in securing approvals for product launches, maintaining certifications, and upholding the highest standards of quality within the organization.

What You'll Do

- Develop and implement strategies to oversee and enhance Regulatory Affairs and Quality Assurance operations in alignment with company objectives.

- Lead the Regulatory Affairs team in managing submissions for product approvals, licenses, and registrations with regulatory authorities, including FDA 510(k), MDR and other entities depending on our business strategy.

- Ensure compliance with relevant regulations and standards governing software development (firmware, Apps, fitting software) and medical device manufacturing, distribution, and post-market surveillance, including adherence to MDR requirements.

- Establish and maintain quality management systems to meet regulatory requirements and certifications. Work with process owners to make sure the required deliverables are created at the right moment.

- Conduct audits, assessments, and inspections to identify areas for improvement and ensure adherence to quality standards.

- Collaborate with cross-functional teams to address regulatory and quality issues, drive continuous improvement initiatives, and enhance product quality.

- Maintain relationships with regulatory bodies, certification agencies, and external auditors to ensure compliance with quality and regulatory requirements.

- Develop and implement training programs to enhance staff awareness of regulatory and quality requirements.

- Monitor key performance indicators related to Regulatory Affairs and Quality Assurance and provide regular reports to senior management.

- Stay informed about industry trends, regulations, and best practices to drive innovation and maintain compliance.

- Provide input to product management teams for future products.

What You'll Bring

- Bachelor's degree or higher in a relevant field such as Regulatory Affairs, Quality Assurance, or a related discipline.

- Extensive experience in Regulatory Affairs and Quality Assurance roles within the medical device industry, with familiarity in the hearing aids sector being a plus.

- Profound knowledge of quality management systems, regulatory requirements, and standards in the North American and European markets (e.g., ISO 13485, FDA regulations, MDR, MDD).

- Strong leadership skills with the ability to motivate and develop a team to achieve departmental goals.

- Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.

- Analytical mindset with the ability to identify issues, propose solutions, and drive process improvements.

- Detail-oriented with a focus on maintaining high standards of quality and compliance.

- Certification in Regulatory Affairs or Quality Management Systems (e.g., RAC) is preferred.

- Outstanding English communication and coordination skills, with a team-oriented approach to effectively manage interdepartmental communication and collaboration.

- Ability to think proactively, critically, and independently to make good decisions; an inquisitive problem solver.

- Ability to work in a highly dynamic and fast-paced environment with a high degree of change and ambiguity; able to work efficiently under pressure and prioritize.

What We Offer

- An opportunity to make a real impact on people's lives.

- A fast-paced, dynamic, and collaborative work environment.

- A supportive team that values diversity, inclusion, and open communication.

Seniority level

• Seniority level Director

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance
• Industries Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Orka by 2x

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

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

Orka is an innovative VC-backed startup dedicated to revolutionizing the hearing aid market with our groundbreaking products and services. Our mission is to improve lives by developing exceptional hearing aids that cater to individual needs while incorporating cutting-edge technology, to transform people's hearing journey from chaos to simplicity. As we continue to expand, we are looking for an exceptional RA&QA expert to join our growing team.

The Role

As the Head of Regulatory Affaris & Quality Assurance at our medical device company, you will be responsible for leading the Regulatory Affairs and Quality Assurance functions. Your role is critical in ensuring compliance with regulatory standards, maintaining quality control processes, and driving the company's adherence to industry regulations. You will play a key role in securing approvals for product launches, maintaining certifications, and upholding the highest standards of quality within the organization.

What You'll Do

- Develop and implement strategies to oversee and enhance Regulatory Affairs and Quality Assurance operations in alignment with company objectives.

- Lead the Regulatory Affairs team in managing submissions for product approvals, licenses, and registrations with regulatory authorities, including FDA 510(k), MDR and other entities depending on our business strategy.

- Ensure compliance with relevant regulations and standards governing software development (firmware, Apps, fitting software) and medical device manufacturing, distribution, and post-market surveillance, including adherence to MDR requirements.

- Establish and maintain quality management systems to meet regulatory requirements and certifications. Work with process owners to make sure the required deliverables are created at the right moment.

- Conduct audits, assessments, and inspections to identify areas for improvement and ensure adherence to quality standards.

- Collaborate with cross-functional teams to address regulatory and quality issues, drive continuous improvement initiatives, and enhance product quality.

- Maintain relationships with regulatory bodies, certification agencies, and external auditors to ensure compliance with quality and regulatory requirements.

- Develop and implement training programs to enhance staff awareness of regulatory and quality requirements.

- Monitor key performance indicators related to Regulatory Affairs and Quality Assurance and provide regular reports to senior management.

- Stay informed about industry trends, regulations, and best practices to drive innovation and maintain compliance.

- Provide input to product management teams for future products.

What You'll Bring

- Bachelor's degree or higher in a relevant field such as Regulatory Affairs, Quality Assurance, or a related discipline.

- Extensive experience in Regulatory Affairs and Quality Assurance roles within the medical device industry, with familiarity in the hearing aids sector being a plus.

- Profound knowledge of quality management systems, regulatory requirements, and standards in the North American and European markets (e.g., ISO 13485, FDA regulations, MDR, MDD).

- Strong leadership skills with the ability to motivate and develop a team to achieve departmental goals.

- Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.

- Analytical mindset with the ability to identify issues, propose solutions, and drive process improvements.

- Detail-oriented with a focus on maintaining high standards of quality and compliance.

- Certification in Regulatory Affairs or Quality Management Systems (e.g., RAC) is preferred.

- Outstanding English communication and coordination skills, with a team-oriented approach to effectively manage interdepartmental communication and collaboration.

- Ability to think proactively, critically, and independently to make good decisions; an inquisitive problem solver.

- Ability to work in a highly dynamic and fast-paced environment with a high degree of change and ambiguity; able to work efficiently under pressure and prioritize.

What We Offer

- An opportunity to make a real impact on people's lives.

- A fast-paced, dynamic, and collaborative work environment.

- A supportive team that values diversity, inclusion, and open communication.

Seniority level

• Seniority level Director

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance
• Industries Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Orka by 2x

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

3 days ago Be among the first 25 applicants

For over 15 years, Camber Pharmaceuticals has been one of the fastest-growing generics companies in the United States. Since its inception, Camber has shown a tradition of excellence and a deep commitment to providing cost-effective processes to treat a wide range of therapeutic categories.

Through our parent company, Hetero ( Camber is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development, and commercialization. Hetero is India’s largest privately held pharmaceutical company and a world leader in API production, with a strong global presence in over 126 countries.

Saving lives is our passion, and we continue to help shape a healthier world through affordable medications.

About the Role

We are seeking an experienced Regulatory Affairs Manager with expertise in drug registration, dossier submissions, and HA (Hospital Authority) tendering processes in Hong Kong. In this role, you will ensure compliance with local regulatory requirements, manage submissions to the Department of Health (DH), and support tender applications for public hospital listings.

This is a great opportunity for a detail-oriented regulatory professional who thrives in a fast-paced environment and enjoys working closely with cross-functional teams to bring pharmaceutical products to market.

Key Responsibilities

• Prepare, review, and submit drug registration dossiers (CTD/eCTD format) to the Hong Kong Department of Health (DH) and other regulatory bodies.
• Monitor and interpret evolving regulatory requirements for pharmaceuticals in Hong Kong.
• Manage the HA tendering process, including preparation of tender documents, compliance checks, and post-submission follow-ups.
• Liaise with health authorities, internal stakeholders, and third-party vendors** to ensure smooth regulatory approvals.
• Conduct gap analyses for existing and new product registrations to ensure compliance.
• Maintain up-to-date knowledge of ICH, ASEAN, and local regulatory guidelines.
• Support post-approval variations, renewals, and labeling updates** as needed.
• Collaborate with Quality Assurance, Pharmacovigilance, and Commercial teams to align regulatory strategies.

Qualifications & Experience

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related field.
• 4+ years of hands-on experience in Drug registration & dossier submissions in Hong Kong (CTD/eCTD), HA tendering process (public hospital procurement submissions) .
• Knowledge in regulatory compliance for pharmaceuticals (HK DH, PMDA, FDA, or EMA experience a plus).
• Strong analytical skills with the ability to interpret complex regulatory guidelines.
• Excellent communication skills (written & verbal) in English and Cantonese (Mandarin a plus).
• Proactive, detail-oriented, and able to manage multiple deadlines.
• Experience working with CROs, regulatory agencies, or pharmaceutical companies preferred.

Why Join Us?

MPF + Medical insurance coverage.

18 days annual leave

Opportunity to work on diverse regulatory projects in a dynamic team.

If you are a Regulatory Affairs professional with expertise in drug registration and HA tenders, we would love to hear from you! Apply now or share this opportunity with your network.

#RegulatoryAffairs #PharmaJobs #HongKongJobs #DrugRegistration #HATendering #LinkedInJobs #Hiring

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Legal
• Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Camber Pharmaceuticals Inc by 2x

Sign in to set job alerts for “Regulatory Affairs Manager” roles. Manager, Operation Risk, Life Operations Engineering & Compliance Manager (Trading Company)

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Kwun Tong District, Hong Kong SAR 9 months ago

Identity and Access Management (IAM) Senior Engineer

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

1 day ago Be among the first 25 applicants

Direct message the job poster from H&H Group | B Corp

Talent Acquisition | Business Partnering | Regional Hiring | Employee engagement

A bit about H&H Group

Health & Happiness (H&H) Group is a publicly traded company, with established market positions in more than 15 countries in Asia-Pacific, Europe, North America and Oceania with over 3,300 team members working across the globe. Our vision is focused on premium nutrition and lifetime wellness, backed by science. We have 3 business segments – Baby, Adult and Pet Nutrition and Care – supporting whole-family health and happiness across 7 international brands.

On our journey to making a positive difference across the world, you will work with passionate people in an innovative and collaborative organization as we inspire wellness through #PurposeLedCareers!

We are passionate about our customers and community and are looking for similar-minded talent to join us! As an equal opportunity employer, we care deeply about creating an inclusive workplace where our team members feel valued, respected, and empowered.

Your role within the team

Support the implementation of regulatory strategies and affairs for all products, ensuring regulatory compliance of the company’s products and its license renewal etc. including ingredients, labelling, packaging, and claims, safeguarding the company’s reputation with customers and regulatory agencies for the assigned markets.

Key responsibilities include

• Regulatory management of Supplement/Nutrition/OTC/Skincare products for assigned markets and categories.
• Lead and expedite the product registrations, work across internal departments including Innovation, Product Development, Quality Assurance, Operations, Commercial teams, and external parties including contract manufacturers, regulatory agents, distributors, to prepare and submit the dossier documents for authorities’ approval.
• Review and approve all packaging materials, marketing and training tools to comply with local regulations
• Co-ordinate with internal departments to facilitate new product development, its commercialization and product launch.
• Develop and manage regulatory strategies. Prepare and implement the annual registration plan according to business need and dossier readiness.
• Organize and maintain regulatory database, files and tracking sheets. Ensure appropriate archiving of all relevant documentation in the appropriate systems.
• Monitor evolving regulations in target markets, providing strategic insights on upcoming changes, potential impacts, and recommended actions. Proactively identify and mitigate regulatory risks to minimize business disruptions.
• Answer customer enquiries and provide best in class solution when required.
• Serve as the key liaison between regulatory bodies and internal teams, ensuring alignment on all compliance matters.
• Collaborate cross-functionally to maintain product supply continuity while adhering to regulatory standards.
• Conduct as requested regulatory activities and any ad hoc project as assigned

Desired Skills and Experiences,

• Bachelor’s degree holder in health-related science, life science; Pharmacy or Medical degree desirable
• 8+ years’ experience in similar field/job function, in consumer health care products experiences will be an advantage
• A proactive problem-solver with analytical thinking, independent, fast-paced and self-driven.
• Fluent in English, Cantonese, and Putonghua (written and verbal)
• Strong interpersonal skills, with the ability to engage stakeholders at all levels
• Highly organized, resourceful, and capable of managing multiple priorities
• Have a profound understanding of food industry compliance work and possess certain industry resources
• Basic understanding of technical regulations (testing and specification) and GMP, GVP, GCP etc. is required
• Occasional travel as required
• Candidate with less experience may be considered as Assistant Manager

H&H Group believes in the benefits of a diverse and inclusive workplace and aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination and harassment, creating a safe and inclusive environment for all.

We encourage applications from people of all ages, nationalities, religions, racial and gender identities, sexual orientations, abilities and cultures, and our hiring decisions will be based on business needs, position requirements, and the qualifications and experience of individuals. If you require support or assistance during the application process, please notify us at the time of application and we will be sure to enable reasonable adjustments where suitable.

If you have what it takes, please apply via the online portal and we will be in touch soon. We move quickly and may fill the role prior to the application close date, so we suggest you get in touch today!

Salary and benefits will be competitive and commensurate with experience. All personal data collected is for recruitment purposes only.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance, Research, and Product Management
• Industries Personal Care Product Manufacturing, Pharmaceutical Manufacturing, and Retail Health and Personal Care Products

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