48 Financial Regulations jobs in Hong Kong

Tasks & Responsibilities

-Secure timely and successful marketing authorizations in alignment with Local/Regional/Corporate strategies and plans.

-Maintain the regulatory status of registered products, including managing variation submissions in accordance with company and regulatory authority requirements.

-Ensures local implementation and compliance with Corporate Policies, Processes, Procedures, and Guidelines relevant to regulatory affairs activities.

-Stay informed about local legislation, regulations, and guidelines related to drug registration and pharmacovigilance. Provide feedback to local management and Regional/Corporate regulatory affairs teams on significant changes and future developments.

-Develop and build knowledge for the effective use and maintenance of BI systems and databases.

-Assist in quality-related activities, including local batch release, product complaint and deviation reporting

Requirements

-Previous experience in regulatory affairs within a multinational pharmaceutical company is advantageous. Fresh graduates with relevant knowledge are also welcomed.

-Bachelor's degree in life-science related disciplines such as Pharmacy, Biochemistry, Biology, Biopharmaceuticals, Pharmacology or relevant science subjects.

-Knowledge in local health authority regulations, including new drug applications, change of registered particulars, etc.

-Detail-oriented, team player, collaborative, passionate and strong learning agility

Ready to Contact Us?

Please contact our Recruiting Team: HK:

Position Area

Regulatory Affairs

Position Location

Hong Kong

Organization

Boehringer Ingelheim (HK) Ltd.

Schedule

Full time

A well-established multinational medical device company is looking for a RA Specialist to join their team.

Job 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

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
• Strong interpersonal communication skills
• Self-starter, highly motivated with attention to details
• Able to work independently, by taking general concepts and direction to produce desirable outcomes
• Ability to prioritize multiple tasks and to function effectively
• Excellent command of written and spoken English and Chinese

(All personal data collected will be kept confidential and is for recruitment purpose only.)

EA No. 79133

Job Description:

• We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration.

Responsibilities:

1. Regulatory Strategy & Submissions
   
   • Lead NMPA registration processes for medical devices, including product classification, technical documentation preparation (e.g., risk assessment, clinical evaluation reports), and coordination with testing laboratories
   
   • Manage overseas regulatory registrations (FDA, CE, UKCA), ensuring compliance with regional requirements (e.g., FDA 510(k)/PMA, EU MDR/IVDR, UKCA technical files)
   
   • Collaborate with R&D, QA/QC, and manufacturing teams to align product development with regulatory standards
2. Quality & Compliance Oversight
   
   • Ensure adherence to ISO 13485 and GMP standards across product lifecycle, including design controls, production processes, and post-market surveillance
   
   • Conduct internal audits and support external audits by regulatory bodies (e.g., NMPA, FDA, Notified Bodies)
3. Regulatory Intelligence & Training
   
   • Monitor updates in global regulations (NMPA, FDA, EU, UK) and communicate impacts to internal stakeholders
   
   • Develop training programs for cross-functional teams on regulatory requirements and compliance
4. Cross-functional Collaboration
   
   • Liaise with external partners, including CROs, testing agencies, and regulatory consultants, to expedite approvals
   
   • Support international market expansion by addressing regional regulatory barriers

General Qualification:

Education:

• Bachelor's degree or higher in Life Sciences, Biomedical Engineering, or related fields. Advanced degrees (e.g., MSc, PhD) preferred.

Experience:

• 5+ years in medical device regulatory affairs with proven success in NMPA registrations and at least 2 FDA/CE/UK approvals;
  
  In-depth knowledge of ISO 13485, GMP, and quality system standards;

Skills:

• Proficiency in technical documentation (e.g., design dossiers, clinical evaluation plans)
  
  Strong project management and communication skills for global regulatory coordination.

Language:

• Fluency in English and Mandarin (written and spoken) to liaise with global teams and authorities

Preferred Qualifications:

• Experience with software-as-a-medical-device (SaMD) or AI-driven medical technologies Certification in regulatory affairs (e.g., RAC, CE Marking expertise)

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.

Key Responsibilities

• Drive medical device regulatory submissions in accordance with relevant regulations and company's strategy
• Ensure that submissions are of high quality, meet all regulatory requirements and compliance with company goals and directives
• Effectively communicate and coordinate among internal and external stakeholders to achieve regulatory objectives
• Keep abreast of relevant regulations, guidelines and industry practice
• Provide training and guidance to internal teams on regulatory requirements and procedures, including new and upcoming changes
• Ensure all regulatory files are archived and maintained in accordance with company SOPs
• Ensure QMS requirements on regulatory-related matters are fulfilled
• Review marketing materials and labelling to maintain compliance with global and internal requirements

Supportive responsibilities

• Contribute to regulatory research and strategy planning of new pipelines
• Support other regulatory topics in collaboration with cross-functional team, e.g. R&D, Quality, Business Development, Marketing etc.

Requirements

• Bachelor's degree or higher in life science, engineering or related fields
• At least 5 years regulatory affairs experience with track record in obtaining Class II or above electronic medical device approval in US, EU or China, preferably with ultrasound devices
• Extensive knowledge and experience in global medical device regulations, requirements and standards, such as US 510(k), De Novo, FDA QSR, EU MDR, ISO 13485, IEC 60601, ISO 14155, ISO 14971, ISO 62304, and other technical standards applicable to electronic / ultrasound devices
• Experience in working with multiple cross disciplines in preparing device submission files, e.g. R&D, Manufacturing, Quality, etc.
• Experience in working with external vendors in various disciplines, such as regulatory consultants, local distributors, contract manufacturers
• Candidate with more experience will be considered as Regulatory Affairs Manager, whilst less experience will be considered as Associate Regulatory Affairs Manager
• Excellent verbal and written communication skills in English, Cantonese and Mandarin
• Proficient in MS Office, including Word, Excel and Powerpoint
• Proactive communication and interpersonal skills
• Project management and organization skills
• Attention to detail, analytical abilities and problem-solving skills
• Ability to translate complex regulatory guidelines into simple context and effectively educate cross department stakeholders with diverse background
• Adapted to dynamic working environment and motivated to acquire new knowledge continuously

Benefits

• Medical and dental insurance (Covering spouse and children)
• 5-day Work Week
• Min. 14 Annual Holidays
• Enjoy Special Leave: Birthday Leave, Study Leave, Family Leave, Marriage Leave, Pawternity Leave, etc.
• Fun working culture with challenges to learn and grow together
• Employee Wellness and Support Group

To apply, please send your resume together with present and expected salaries with contact details via email to: Opharmic Technology (HK) Limited, Attn: Ms. Zeta Hung,  

About Opharmic

Founded in 2016, Opharmic is striving towards an ambitious goal: to replace horrifying eye injections around the world with our patented non-invasive ultrasound system. From technology and product customisation, to clinical development and regulatory strategies, Opharmic offers turnkey solution to pharma partners around the world to adopt cutting-edge technology in their new or existing pipelines.

Job Description:

• We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration.

Responsibilities:

1. Regulatory Strategy & Submissions
   
   • Lead NMPA registration processes for medical devices, including product classification, technical documentation preparation (e.g., risk assessment, clinical evaluation reports), and coordination with testing laboratories
   
   • Manage overseas regulatory registrations (FDA, CE, UKCA), ensuring compliance with regional requirements (e.g., FDA 510(k)/PMA, EU MDR/IVDR, UKCA technical files)
   
   • Collaborate with R&D, QA/QC, and manufacturing teams to align product development with regulatory standards
2. Quality & Compliance Oversight
   
   • Ensure adherence to ISO 13485 and GMP standards across product lifecycle, including design controls, production processes, and post-market surveillance
   
   • Conduct internal audits and support external audits by regulatory bodies (e.g., NMPA, FDA, Notified Bodies)
3. Regulatory Intelligence & Training
   
   • Monitor updates in global regulations (NMPA, FDA, EU, UK) and communicate impacts to internal stakeholders
   
   • Develop training programs for cross-functional teams on regulatory requirements and compliance
4. Cross-functional Collaboration
   
   • Liaise with external partners, including CROs, testing agencies, and regulatory consultants, to expedite approvals
   
   • Support international market expansion by addressing regional regulatory barriers

General Qualification:

Education:

• Bachelor's degree or higher in Life Sciences, Biomedical Engineering, or related fields. Advanced degrees (e.g., MSc, PhD) preferred.

Experience:

• 5+ years in medical device regulatory affairs with proven success in NMPA registrations and at least 2 FDA/CE/UK approvals;
  
  In-depth knowledge of ISO 13485, GMP, and quality system standards;

Skills:

• Proficiency in technical documentation (e.g., design dossiers, clinical evaluation plans)
  
  Strong project management and communication skills for global regulatory coordination.

Language:

• Fluency in English and Mandarin (written and spoken) to liaise with global teams and authorities

Preferred Qualifications:

• Experience with software-as-a-medical-device (SaMD) or AI-driven medical technologies Certification in regulatory affairs (e.g., RAC, CE Marking expertise)

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?

• Competitive salary
• Medical insurance coverage.
• 18 days annual leave + public holidays.
• 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.

Job Type: Full-time

Pay: $37, $45,000.00 per month

Benefits:

• Employee pension
• Medical Insurance
• Professional development

Application Question(s):

• Do you have experience in HKD drug registration and tendering?

Language:

• Cantonese (Required)

Work authorization:

• Hong Kong (Required)

Work Location: In person

Our client, a US multinational conglomerate operating in the fields of industry, work safety, healthcare, and consumer goods, who is looking for a Regulatory Affairs Associate.

The Impact You'll Make in this Role?

As a Regulatory Affairs Associate, you will have the opportunity to collaborate with some of the most innovative and diverse people around the world. Here you will make an impact by:

• Preparing regulatory submission documents to authority for Wholesale Dealer License and product registration.
• Supporting authority request and responding to authority enquiries for license application and maintenance.
• Collaborating with global and cross-functional team to manage open requests and deficiencies.
• Other ad-hoc tasks as assigned by manager.

(This position is a full-time position with 1-year contract period, with the possibility to renewal subject to mutual agreement)

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's Degree holder in Pharmacy, Science, Engineering or any health care-related discipline.
• At least 2 year of experience in regulatory affairs role in pharmaceutical, medical device or health care industry.
• Additional qualifications that could help you succeed even further in this role include:
• Sound knowledge of local regulatory environment and regulations.
• Good command of both written and spoken English and Chinese, both Cantonese and Mandarin.
• Excellent computer literacy, good interpersonal, communication and project management skills.
• Team player with high degree of integrity and responsibility. Organized, detail-minded and flexible.

Details

• Mon – Fri, 9am – 6pm, Kowloon Bay
• Tentative package: Annual leave, Medical Insurance, Paid Sick Leave, MPF

To apply for this position,  please simply click on the "APPLY" button or send your full resume to in word format indicating the job title.  If you are not contacted by our consultants within 2 weeks, please consider your application unsuccessful. All applications will be treated in strict confidence, and used for recruitment purposes only in accordance with PERSOLKELLY Hong Kong Limited's Privacy Notice.

PERSOLKELLY Hong Kong Limited: Employment Agency License No. 79017

PERSOL Hong Kong: Employment Agency License No. 79006

Key Roles and Responsibilities

• Liaise closely with internal departments and external stakeholders on upcoming changes to regulations, pharmaceutical products and medical devices;
• Coordinate the timely registration of new pharmaceutical products and medical devices, manage change applications for products/devices and handle registration certificate renewals;
• Maintain product registration dossiers and monitor submission timelines;
• Prepare and submit technical documentation to Regulatory Authorities and assist with tender documentation;
• Handle all regulatory related matters, including the review of product packaging, promotional materials and marketing materials to meet regulatory compliance;
• Perform local batch release and support any other ad-hoc tasks as assigned by the Manager.

Qualifications and Experience

• Bachelor degree in Pharmaceutical sciences, chemistry, biochemistry, biology or related life sciences;
• 1+ years of work experience in pharmaceutical regulatory affairs is preferred;
• Excellent communication and interpersonal skills to work with people of different levels and cultures;
• Able to work independently with good organization skills, highly self-motivated and detail oriented;
• Proficiency in both written and spoken English;
• Immediately available is highly preferred.

How to Apply

You are invited to send in your application and CV stating the position with reference number JGM or mail Room , Tower 1, Millennium City 1, 388 Kwun Tong Road, Kwun Tong, Kowloon on or before 3 November 2025.

Jacobson Group Management Limited is an Equal Opportunities Employer. Personal data provided by job applicants will be used strictly in accordance with our personal data policy and for recruitment purposes only. We aim to respond to successful applicants within 8 weeks and related information will be kept in our file for up to 12 months for other suitable vacancies in our organization and thereafter destroyed.