Job Details
An expanding global Contract Research Organisation (CRO) is looking for a Director, Regulatory Affairs (APAC) to lead its regulatory team and drive strategy across the region.
This is an exciting leadership role where you'll shape submissions, guide regulatory strategy, and represent the company in high-level interactions with Health Authorities worldwide.
What You'll Do:
- Lead and develop regional regulatory teams (Regulatory Managers, Senior Regulatory & Start-Up Specialists) across APAC, including China, South Korea, Taiwan, and Singapore
- Provide regulatory strategy and oversight for clinical trial and drug development submissions, including IND/CTA/CTN, amendments, and expedited pathways
- Represent the company in direct interactions with Health Authorities across APAC
- Partner with internal stakeholders and project teams to drive regulatory excellence and corporate growth
- Support business development initiatives with regulatory insights and proposals
What We're Looking For:
- 10+ years in Regulatory Affairs with proven CRO experience
- Extensive regional regulatory expertise across APAC (China, Australia, South Korea, Taiwan, Malaysia, Philippines)
- Strong track record with IND/CTA/CTN submissions and direct Health Authority interactions
- Experienced people leader with the ability to build, mentor, and inspire teams
- Excellent communication skills in English for internal & external communications and engagement with the ability to engage effectively across diverse APAC markets, particularly within China.
This is your chance to make an impact by building and leading a regulatory function during a transformative period of growth in the APAC region.
If you're an aspirational leader ready to shape the future of clinical development, we'd love to hear from you.
Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112
