22 Financial Regulations jobs in Hong Kong

Overview

Regional Talent Acquisition | Human Resources | Employer Branding | Life Science & Pharmaceuticals

Job Description

Regulatory Affairs, compliance and administrative duties
Countries in the scope of responsibilities: ASEAN countries
Regulatory Affairs

Responsibilities

• Drive drug & medical device registrations and variations in accordance with relevant regulations and develop regulatory strategy to obtain the product approval within target timeframe.
• Maintain Guerbet products’ licenses in responsible countries
• Keep abreast of regulatory procedures and product changes to ensure registration dossiers are maintained in compliance with local and corporate instructions.
• Effectively communicate and collaborate with local RAs and HQ RA team in France and US in order to develop Regulatory Strategies
• Provide local regulation intelligence to internal stakeholders
• Maintain registration database locally
• Support other regulatory topics in collaboration with cross-functional team, e.g. commercial, marketing and supply chain etc.

Compliance and Administrative Duties

• Ensure company’s products comply with the regulations
• Plan and coordinate packaging changes with related departments
• Ensure validation of promotional materials in compliance with local regulations and corporate policy.
• Maintain accurate information in product labeling by collaborating with distributors and ensure compliance with local labelling requirements

Profile Description Education & Experience

• Bachelor’s degree in health-related science, life science; Pharmacist or related academic background is preferred
• 3-4 years of relevant experience in pharmaceutical registration and experience in medical device registration in ASEAN countries and/or Hong Kong is preferred
• Candidate with more experience will be considered as Senior Regulatory Affairs Specialist, whilst less experience will be considered as Regulatory Affairs Specialist

Skills & Qualifications

• Excellent verbal and written communication skills in English and Cantonese
• Proficient in MS Office, including Word, Excel and PowerPoint
• Previous experience in a multinational environment
• Effective communication and interpersonal skills
• Detail-oriented and cross-functional team player
• Work precisely according to procedures, rules and regulations
• Recognize recurring issues and analyse their causes in order to reach a solution

We Offer

To learn more and to apply, feel free to visit our website:

Reasons to join us

• Much more than a competitive salary, we offer continued personal development, we offer an interesting opportunity to join our global team and be part of our Global Technical Operations Leadership Team.
• Are choosing the world’s leader in the technological sector of diagnostic and interventional imaging,
• Are joining our 2600 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life in more than 80 countries all over the world,
• Are joining a company where we value our diverse team coming from various horizons.

We # Achieve # Cooperate # Care # Innovate at Guerbet.

To learn more and to apply, feel free to visit our website:

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance, Research, and Science

Industries

• Pharmaceutical Manufacturing

Location: Kowloon City District, Hong Kong SAR

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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.

#J-18808-Ljbffr

Senior Specialist, Regulatory Affairs
Date: Sep 2, 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

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

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.

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Product Compliance & Regulatory Affairs Engineer

We are seeking a Product Compliance & Regulatory Affairs Engineer to ensure our kids’ consumer electronics meet all relevant international safety and regulatory standards. This role will manage compliance labelling, product certifications, regulatory product testing, and technical documentation throughout the product lifecycle.

About Yoto

Yoto is a screen-free interactive audio platform for kids. We make carefully connected audio players that kids control, with no microphones, cameras or ads. We have a catalogue of audio that inspires creative play and learning with 1,000+ titles in our card store from top creators, publishers and labels - think Disney, Marvel, Roald Dahl and Universal Music. We also create Yoto Originals like this one.

• Voted the 14th fastest-growing private software technology company in Britain in The Sunday Times 100 Tech 2025; and named the 94th fastest-growing company in Europe in the prestigious FT1000.
• Ranked 9th in Fast Company's Most Innovative Companies in 2024; and featured in the Sifted 100 fastest-growing startups across the UK&I by revenue growth.
• Featured in Bloomberg’s 25 UK startups to watch in 2023; and ranked second fastest growing tech company in the UK in the Deloitte Fast50.
• Named one of TIME Magazine’s Top 100 Inventions of 2020.
• We’re 200 employees spread across the UK, US, France, Australia, Canada, Singapore, the Netherlands, Romania and China, and growing!

We’re on a mission to be the soundtrack of childhood, and help families on their own unique adventures. By creating products that inspire independent play, we help families discover and grow with an inspiring world of audio - and we would like you to help us achieve it!

What you’ll be doing

• Ensure all products comply with international standards and regulations for children’s electronics and toys (e.g., EN71, ASTM F963, CPSIA, FCC, RoHS, REACH).
• Define and verify compliance labeling and product copy (warnings, user instructions, age grading, certification marks) for products, packaging, and manuals.
• Manage external compliance testing and certification processes, including defining test plans, selecting and coordinating with third-party labs, and ensuring timely completion for global markets.
• Interpret and apply international standards; provide guidance to internal teams on regulatory requirements and best practices.
• Review and approve technical documentation (declarations of conformity, technical files, test reports) to ensure audit readiness and compliance with market entry requirements.
• Monitor regulatory changes and emerging requirements; proactively conduct regulatory horizon scanning to identify, assess, and anticipate new laws, regulations, and policy initiatives that may impact the organisation; update internal processes, documentation, and product standards as needed.
• Collaborate with design, marketing, and supply chain teams to embed compliance information early in development.
• Serve as the primary point of contact for all product compliance and regulatory matters.

What you’ll bring

• Experience in product compliance for kids’ consumer electronics or toys.
• Strong knowledge of international safety and regulatory standards.
• Experience managing external product testing and certification.
• Excellent documentation and organisational skills.
• Fluent in English and Mandarin, with strong communication abilities.
• Detail-oriented and proactive in monitoring regulatory changes.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Consumer Electronics

#J-18808-Ljbffr

1 day ago Be among the first 25 applicants

Direct message the job poster from Camber Pharmaceuticals Inc

Business Development Manager | Business Operations | Marketing Strategies | Partnership & Alliance | Revenue Generation |

About Camber Pharmaceuticals

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

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

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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Product Compliance & Regulatory Affairs Engineer

We are seeking a Product Compliance & Regulatory Affairs Engineer to ensure our kids’ consumer electronics meet all relevant international safety and regulatory standards. This role will manage compliance labelling, product certifications, regulatory product testing, and technical documentation throughout the product lifecycle.

About Yoto

Yoto is a screen-free interactive audio platform for kids. We make carefully connected audio players that kids control, with no microphones, cameras or ads. We have a catalogue of audio that inspires creative play and learning with 1,000+ titles in our card store from top creators, publishers and labels - think Disney, Marvel, Roald Dahl and Universal Music. We also create Yoto Originals like this one.

• Voted the 14th fastest-growing private software technology company in Britain in The Sunday Times 100 Tech 2025; and named the 94th fastest-growing company in Europe in the prestigious FT1000.
• Ranked 9th in Fast Company's Most Innovative Companies in 2024; and featured in the Sifted 100 fastest-growing startups across the UK&I by revenue growth.
• Featured in Bloomberg’s 25 UK startups to watch in 2023; and ranked second fastest growing tech company in the UK in the Deloitte Fast50.
• Named one of TIME Magazine’s Top 100 Inventions of 2020.
• We’re 200 employees spread across the UK, US, France, Australia, Canada, Singapore, the Netherlands, Romania and China, and growing!

We’re on a mission to be the soundtrack of childhood, and help families on their own unique adventures. By creating products that inspire independent play, we help families discover and grow with an inspiring world of audio - and we would like you to help us achieve it!

What you’ll be doing

• Ensure all products comply with international standards and regulations for children’s electronics and toys (e.g., EN71, ASTM F963, CPSIA, FCC, RoHS, REACH).
• Define and verify compliance labeling and product copy (warnings, user instructions, age grading, certification marks) for products, packaging, and manuals.
• Manage external compliance testing and certification processes, including defining test plans, selecting and coordinating with third-party labs, and ensuring timely completion for global markets.
• Interpret and apply international standards; provide guidance to internal teams on regulatory requirements and best practices.
• Review and approve technical documentation (declarations of conformity, technical files, test reports) to ensure audit readiness and compliance with market entry requirements.
• Monitor regulatory changes and emerging requirements; proactively conduct regulatory horizon scanning to identify, assess, and anticipate new laws, regulations, and policy initiatives that may impact the organisation; update internal processes, documentation, and product standards as needed.
• Collaborate with design, marketing, and supply chain teams to embed compliance information early in development.
• Serve as the primary point of contact for all product compliance and regulatory matters.

What you’ll bring

• Experience in product compliance for kids’ consumer electronics or toys.
• Strong knowledge of international safety and regulatory standards.
• Experience managing external product testing and certification.
• Excellent documentation and organisational skills.
• Fluent in English and Mandarin, with strong communication abilities.
• Detail-oriented and proactive in monitoring regulatory changes.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Consumer Electronics

#J-18808-Ljbffr

1 day ago Be among the first 25 applicants

Direct message the job poster from Camber Pharmaceuticals Inc

Business Development Manager | Business Operations | Marketing Strategies | Partnership & Alliance | Revenue Generation |

About Camber Pharmaceuticals

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

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

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