Job Description

Job Details
Location
Singapore
Salary
Competitive Salary
Job Type
Ref
BH-24008-1
Contact
Posted
about 21 hours ago
Job Details
Location
Singapore
Salary
Competitive Salary
Job Type
Ref
BH-24008-1
Contact
Posted
about 21 hours ago Global Contract Research Organisation (CRO)
? Location: Singapore (Flexible)
We are an expanding global Contract Research Organisation (CRO) dedicated to advancing clinical research and improving patient outcomes worldwide. As part of our continued growth across the Asia-Pacific region, we are seeking an experienced and visionary Director, Regulatory Affairs (APAC) to lead our regional regulatory function.
This is an exciting opportunity to play a pivotal role in shaping regulatory strategy, guiding submissions, and partnering with global teams to drive clinical development success across diverse APAC markets.
The Role
As Director, Regulatory Affairs (APAC), you will:

• Lead and develop regulatory teams across APAC, including China, South Korea, Taiwan, and Singapore.
• Define and implement regional submission strategies for clinical trials and drug development (IND, CTA, CTN, amendments, and expedited pathways).
• Represent the organisation in direct interactions with Health Authorities, providing expert guidance and strategic input.
• Collaborate cross-functionally with internal stakeholders to ensure regulatory alignment throughout all project stages.
• Contribute to business development initiatives by providing regulatory insights and supporting client proposals.

You will be part of a global leadership community, working with colleagues who share a commitment to quality, innovation, and scientific excellence.
About You
We are looking for a dynamic and experienced regulatory leader who brings:

• 10+ years in Regulatory Affairs, preferably within a CRO or clinical research environment.
• Extensive regulatory knowledge across key APAC markets (China, Australia, South Korea, Taiwan, Malaysia, Philippines).
• Proven experience leading IND/CTA/CTN submissions and engaging with regional Health Authorities.
• Strong leadership, mentoring, and communication skills with the ability to drive performance across diverse teams.

Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112

Skills Required