Global Clinical & Regulatory Strategy Lead

Advanced Biomedical Instrumentation Centre ABIC; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Advanced Biomedical Instrumentation Centre ABIC is seeking a Senior Clinical & Regulatory Affairs Specialist to lead global regulatory strategies across FDA, NMPA, EMA, PMDA, and other bodies. You will design and manage plans for regulatory approvals from pre-clinical to clinical trials, and prepare dossiers while presenting regulatory roadmaps to investors and partners.

You will act as the primary liaison with regulators, CROs, medical professionals, and investors, overseeing budgets and

Qualifications

• PhD in Healthcare, Life Sciences, or related field.
• 5+ years in pre-clinical operations and clinical studies with hospital IRBs and regulatory approvals.
• Proven knowledge of regulatory requirements for medical devices/biologics in major markets (FDA, NMPA, EMA, PMDA).
• Experience writing and submitting regulatory dossiers and responding to authority queries.
• Corporate R&D hands-on experience and ability to manage cross-functional projects.

Responsibilities

• Study regulatory strategies for biomedical technologies across FDA, NMPA, EMA, PMDA, and other bodies.
• Develop detailed plans for regulatory approval from pre-clinical to clinical trials.
• Draft, explain, negotiate, and deliver regulatory plans to investors, CROs, CDMOs, and clinicians.
• Act as primary contact point for regulators, physicians, investors, and partners; represent ABIC in meetings and produce written materials.
• Manage project budgets and milestones to ensure on-time, on-budget delivery.
• Identify and recruit clinical doctors, hospitals, and groups to participate in studies and secure their support.

Skills

Regulatory affairs

Clinical studies

Dossier preparation

Investor relations

Networking

English & Putonghua

Education

PhD in Healthcare/Life Sciences

Job description

Advanced Biomedical Instrumentation Centre ABIC is seeking a Senior Clinical & Regulatory Affairs Specialist to lead global regulatory strategies across FDA, NMPA, EMA, PMDA, and other bodies. You will design and manage plans for regulatory approvals from pre-clinical to clinical trials, and prepare dossiers while presenting regulatory roadmaps to investors and partners.

You will act as the primary liaison with regulators, CROs, medical professionals, and investors, overseeing budgets and