Associate Director, Regulatory Affairs
Guangzhou
Permanent
Negotiable
PR/585891_1774599160
Associate Director, Regulatory Affairs
Our client is a globally established science‑focused company supporting end‑to‑end development and manufacturing for healthcare and technology partners.
They are currently looking for an Associate Director of Regulatory Affairs to lead regulatory strategy, oversee key submissions, and serve as a trusted partner to internal and external stakeholders across the region.
Responsibilities:
- Develop and implement regulatory strategies for the China market, ensuring alignment with national requirements and broader global regulatory standards.
- Act as the main point of contact for interactions with Chinese regulatory bodies, maintaining clear and consistent communication channels.
- Provide regulatory expertise to internal teams to support product development, technology transfers, manufacturing updates, and overall lifecycle activities.
- Identify potential regulatory challenges and opportunities, offering practical recommendations to guide project teams.
- Support external partners operating in or entering the China market by outlining regulatory pathways and expectations.
- Translate China‑specific regulatory requirements into clear guidance for cross‑functional and global teams to ensure consistency across programs.
- Lead regulatory discussions with authorities, including the preparation and coordination of dossiers, briefings, and responses to regulatory queries.
- Manage end‑to‑end regulatory submission processes, including clinical trial applications, product registrations, and documentation related to manufacturing compliance.
- Partner with regional and global regulatory colleagues to coordinate submissions across development, commercialization, and post‑approval phases.
- Contribute to the growth of regulatory capabilities through team development, coaching, and participation in wider regulatory initiatives.
- Bachelor's degree in a Life Sciences field (e.g., Chemistry, Biochemistry, Biology, Pharmacy).
- At least 10 years of regulatory affairs experience in pharma/biotech.
- Strong knowledge of China regulatory requirements and CMC regulations.
- Existing working relationships with Chinese Health Authorities.
- Understanding of biologics and related manufacturing processes.
- Experience leading or supporting both China and international regulatory interactions.
- Strong project management skills, especially in preparing regulatory/CMC documentation.
If you are interested, please apply with your CV attached.