Senior Regulatory Affairs Specialist

About the role

Regulatory Affairs at BioLink is four people covering pharmaceutical registration, medical devices and the quality system that holds it all together. Small team, wide surface: in the next eighteen months we have two in-licensed specialty products going through Hong Kong registration, a Class II diagnostic device heading for NMPA, and a quality system that needs to survive its first sponsor audit under the new arrangement.

We are hiring at senior level because the previous holder of this seat moved into the VP role and we need someone who can own strategy rather than execute someone else's. You will decide submission sequencing, argue the classification questions, and be the person in the room when a commercial deadline collides with a regulatory reality.

You will report to Dr Marcus Wan, VP of Regulatory & Quality, and work closely with clinical operations, our Shenzhen partner's regulatory lead, and the in-licensing counterparties' regulatory teams in Europe and Japan.

What you'll do

• Own the Hong Kong registration strategy and dossier assembly for two in-licensed specialty pharmaceutical products
• Prepare and lodge submissions to the Drug Office, and manage deficiency responses through to certificate issue
• Lead the NMPA pathway for a Class II in-vitro diagnostic device with our Mainland partner, including technical file and testing arrangements
• Maintain product licences, variations, renewals and labelling changes across the portfolio
• Review promotional and medical-education material for regulatory compliance before release
• Keep the regulatory intelligence log current and brief the leadership team monthly on changes that affect the pipeline
• Act as regulatory lead during sponsor and partner audits of our quality system

What we're looking for

• 6+ years in regulatory affairs covering pharmaceuticals and, ideally, medical devices
• Hands-on experience preparing Hong Kong Drug Office submissions end to end
• Working knowledge of CTD/eCTD structure and at least one of NMPA, TGA or EMA pathways
• Life sciences, pharmacy or biomedical degree
• Business English and Putonghua — Mainland submissions and partner calls run in both
• Able to hold a position with commercial stakeholders when the regulation does not bend

Nice to have

• Experience with in-licensed or parallel-import product registration
• IVD or companion-diagnostic device background
• RAC certification or equivalent regulatory qualification

What you get

• Discretionary bonus and annual salary review
• Medical, dental and life cover for you and dependants
• 20 days annual leave plus Science Park's compressed summer Fridays
• Conference and RAPS membership funded each year
• Visa sponsorship and relocation support for the right candidate