Global Clinical & Regulatory Strategy Lead

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

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