- Lead US IND strategy with direct FDA engagement
- High-impact role ahead of global trial in 2027
About Our Client
Our client is a venture-backed biotechnology platform headquartered in Singapore, focused on acquiring and advancing high-potential therapeutic assets for global development. The organisation operates as a strategic bridge across multiple geographies, including the US and Asia, progressing programmes through key clinical and regulatory milestones.
Backed by a leading global life sciences investor with a strong track record in building successful biotech companies, the business adopts a lean operating model supported by external partners and CROs. With a growing pipeline and plans for global clinical trials beginning in 2027, the company is entering a critical phase of development and scaling its leadership team accordingly.
Job Description
- Lead the design and execution of global regulatory strategies across pipeline assets
- Drive US IND submissions and manage direct interactions with FDA and other health authorities
- Provide hands-on oversight of day-to-day regulatory operations and submissions
- Collaborate cross-functionally to align regulatory strategy with clinical development plans
- Manage external CROs, consultants, and global regulatory partners
- Support due diligence and regulatory assessment for in-licensing opportunities
- Ensure regulatory compliance, risk mitigation, and inspection readiness across programmes
The Successful Applicant
A Successful Director Of Regulatory Affairs Should Have
- 10+ years of experience in regulatory affairs within biotech or pharmaceuticals
- Proven track record leading IND submissions and engaging with the FDA
- Strong background in global regulatory strategy across multiple regions
- Experience operating in lean or early-stage biotech environments
- Demonstrated ability to work both strategically and hands-on
- Track record of managing CROs and external regulatory partners
- Experience supporting cross-border development programmes
What's on Offer
This is an opportunity to join a high-growth biotech platform at a pivotal stage, where you will play a central role in enabling global clinical development and regulatory success. The position offers significant ownership, exposure to senior leadership, and the chance to shape regulatory strategy from the ground up. You will work in a collaborative, entrepreneurial environment with strong investor backing, alongside a competitive compensation structure and long-term value creation potential.
Contact
Quote job ref: JN-072026-7062799
