Associate Director, Regulatory Affairs
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.
- 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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.