Senior Clinical & Regulatory Affairs Specialist

Advanced Biomedical Instrumentation Centre; Hong Kong; On-site; HKD 900,000 - 1,500,000; Full time

Job summary

Advanced Biomedical Instrumentation Centre invites applications for Senior Clinical & Regulatory Affairs Specialist. The role covers regulatory strategy for medical devices, drugs, and software across major markets, including FDA, NMPA, EMA, PMDA, and TGA.

You will lead pre-clinical and clinical planning, author dossiers, and present plans to investors and regulators. You will manage cross-functional teams, coordinate IITs and sponsored trials, and travel frequently to Mainland China and

Qualifications

• PhD degree in Healthcare, Life Sciences, or a related discipline from a university (top 100 world ranking).
• At least 5 years in running pre-clinical operations and clinical studies with regulatory approvals.
• Deep knowledge of regulatory approval processes for medical devices and/or biologics.
• Ability to deliver excellent investor presentations.
• Strong network-building and partner development skills.
• Fluency in English and Putonghua; professional writing in Chinese and English.
• Experience in writing, submitting, and managing regulatory dossiers.
• Corporate R&D hands-on experience is a MUST.

Responsibilities

• Study biomedical technologies and regulatory strategies across US FDA, NMPA, EMA, PMDA, TGA, and others.
• Develop detailed plans to obtain regulatory approval from pre-clinical to clinical stages.
• Draft, explain, negotiate, and present regulatory plans to investors and stakeholders.
• Serve as primary contact with regulatory officers, medical professionals, CROs, CDMOs, and manufacturers.
• Manage project budgets, milestones, and ensure timely completion within budget.
• Identify and recruit clinical doctors, hospitals, and groups for studies.
• Oversee IITs and sponsored trials, including pre-clinical operations.
• Author regulatory documentation including protocols, consent forms, IRB submissions, and progress reports.
• Deliver oral presentations and liaise with clinicians, nurses, lab operators, and logistics staff.
• Source and monitor CDMOs or internal manufacturing for clinical studies and trials.
• Develop and manage QMS for biomedical product development.
• Travel frequently to Mainland China and overseas for meetings.
• Contribute to commercialisation, investor engagement, and business partnerships.
• Share knowledge on pre-clinical/clinical studies and CDMO/CRO management.

Skills

Regulatory affairs

Investor presentations

Networking & relationship building

English & Putonghua proficiency

Dossier writing & submission

Project management

Flexible / outside hours willingness

Education

PhD in Healthcare / Life Sciences or related

Job description

Applications are invited for appointment as Senior Clinical & Regulatory Affairs Specialist (Ref. H01/2026/053).

Job Description

• Study biomedical technologies and products, and investigate pre-clinical and clinical approval strategies at the US FDA, China NMPA, Japan PMDA, European EMA, Australia TGA, and other regulatory bodies.
• Coverage includes medical devices, drugs, and medical computer software, including AI tools and data science applications.
• Develop detailed plans for obtaining regulatory approval, from conducting pre-clinical studies for clinical trial entry, to running and completing clinical trials required for market authorisation.
• Draft, explain, negotiate, and deliver high-quality presentations of regulatory plans to investors, companies, regulatory bodies, medical doctors, CROs, CDMOs, and other relevant stakeholders.
• Act as the primary contact point for regulatory officers, medical professionals, investors, company representatives, research teams, consultants, and manufacturers. Represent ABIC in various meetings and produce all necessary written materials to drive projects forward through effective communication.
• Manage projects by calculating and tracking budgets and expenses, and closely follow up on project milestones to ensure they are executed according to schedule, without delays or budget overruns.
• Identify and recruit clinical doctors, hospitals, and clinical groups to participate in clinical studies. Deliver presentations and negotiate with these parties to secure their support for clinical projects, ensuring they meet the needs and requirements of both ABIC and investors.
• Scope of work includes both Investigator-Initiated Trials (IIT) and sponsored trials, and also pre-clinical operations.
• Demonstrate a comprehensive understanding of conducting clinical studies and serve as the primary author for relevant documentation, including clinical protocols, informed consent forms, collaboration agreements, Institutional Review Board (IRB) submission packs, and progress reports.
• In addition to drafting documents, effectively deliver oral presentations as required.
• Serve as the primary point of contact to support and liaise with clinical doctors, nurses, laboratory operators, and logistics personnel, ensuring the smooth daily operation of projects.
• For pre-clinical development, develop, monitor, and track in-vitro, in-vivo (animal), and data science studies to ensure valid planning and adequate progress towards securing approval from pre-clinical to clinical stages.
• For manufacturing, act as the primary person to source, screen, negotiate contracts with, and monitor the progress of CDMOs or internal manufacturing teams. Ensure products and prototypes are adequately prepared to facilitate the commencement of clinical studies and obtain approval for human trials.
• Develop and execute plans in collaboration with relevant teams to create Drug Development Tools (DDT), New Approach Methodologies (NAMs), ISTAND qualifications, organ-on-chip models, in-silico analyses, and other methodologies intended for qualification by the FDA or other regulatory bodies.
• Develop and manage Quality Management Systems (QMS) for biomedical product development.
• Travel as needed for meetings and work-related duties, under the instruction of ABIC supervisors.
• Frequent travel to the Chinese Mainland and other overseas regions is expected.
• Actively participate in commercialisation activities, including identifying and engaging with investors who support biomedical projects.
• Conduct business pitches, prepare business financial projections, draft agreements, and proactively seek and negotiate business partnerships.
• Play a core role in pitching to stakeholders across both the commercial and government sectors, including investment funds, corporate entities, government units, and science parks.
• Seek business operations and investment opportunities. Act as a proactive, outgoing, and communicative negotiator capable of sourcing and engaging with both scientific and commercial (non-scientific) individuals and organisations.
• Build and maintain strong, trusting relationships with external parties to benefit both the scientific and commercial objectives of the business.
• Share knowledge with, educate, and train both internal and external teams on topics including pre-clinical and clinical studies, qualification and approval processes, and CDMO/CRO management.
• Work flexibly to meet project milestones and coordinate effectively within a team under the supervision of senior staff members of the Centre.
• Perform any other tasks specified by your supervisor that are not mentioned above.
• As ABIC is not a large-scale organisation, you will be expected to undertake a variety of new tasks as required by your supervisor. There are no rigid boundaries to your job scope. Your scope of work is not fixed, and will change when instructed by your supervisor. You must remain flexible regarding your job scope when requested by your supervisor.

Skills And Requirements

• PhD degree in Healthcare, Life Sciences, or a related discipline from a university (with the specific subject area ranked within the world's top 100).
• At least 5 years of experience in running pre-clinical operations, and also clinical studies through hospital IRBs and securing regulatory approvals from FDA, NMPA, EMA and/or PMDA.
• In-depth knowledge of regulatory approval processes and requirements for medical devices and/or biologics across key markets.
• Ability to deliver excellent presentations to investors and business partners.
• Highly outgoing and extroverted personality; very skilled at building networks and relationships with new partners for both commercial and research operations.
• Speaks excellent English and Putonghua; able to write professionally in Chinese and English with high-quality output.
• Proven experience in writing, submitting, and managing regulatory dossiers, including pre-submission meetings and responding to authority queries.
• Corporate R&D hands-on experience is a MUST.
• Ability to quickly learn and acquire highly sophisticated scientific and business knowledge (not just scientific or business alone, but both).
• Capability to independently run projects without close supervision or guidance.
• Highly ambitious and very hardworking (this is not a standard 9:00 a.m.-6:00 p.m. job).
• Willing to work outside normal office hours and on weekends.
• Willing to undertake frequent travels (to both Chinese Mainland and overseas) when requested.

A salary commensurate with qualifications and experience will be offered.

The review of applications will commence as soon as possible and continue until the posts are filled. The personal data provided in your application process will be used for recruitment and other employment-related purpose. The personal data may be transferred and disclosed to, and used by HKU Innovation Holdings Limited and The University of Hong Kong for the above purposes.

We are an equal opportunities employer and welcome applications from all qualified candidates.