We're partnering with a leading global clinical research organization (CRO) seeking an experienced Director of Regulatory Affairs to lead regional regulatory strategy and execution across APAC.
This position offers the opportunity to represent the companies regulatory strategy meetings, and Health Authority interactions - a critical leadership role for someone who can combine scientific depth with commercial awareness and client confidence.
The Role
As Director, Regulatory Affairs, you'll:
- Lead regulatory strategy and oversight across the Asia-Pacific region, supporting global submissions and development programs.
- Act as a key regional representative during client meetings and bid defences, providing scientific and regulatory insight with confidence.
- Guide teams through IND/CTA submissions and interactions with Health Authorities (CDE, MFDS, HSA, TGA, Thai FDA, etc.).
- Mentor and develop regulatory professionals within a collaborative, fast-paced CRO environment.
- Partner cross-functionally to align clinical development, regulatory strategy, and operational delivery.
About You
We're looking for an individual who brings:
- 10+ years experience in Regulatory Affairs within pharma, biotech, or CRO environments (CRO experience strongly preferred).
- Regional APAC experience, ideally across multiple markets (e.g., China, South Korea, Australia, Singapore, Thailand, Japan).
- Proven ability to lead or contribute to IND/CTA submissions and regulatory strategy discussions.
- Strong communication skills with confidence to represent the company in client-facing settings (e.g., bid defences, scientific advice meetings).
- A collaborative, professional approach with the ability to build trust and navigate complex stakeholder landscapes.
