Director, Regulatory Affairs - Biotech Platform
Director, Regulatory Affairs - Biotech Platform
Michael Page- Posted 21 days ago
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Job Description
- Lead US IND strategy with direct FDA engagement
- High-impact role ahead of global trial in 2027
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
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
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: Anurag Garg (Lic No: R1215997 / EA No:18S9099)
Quote job ref: JN-072026-7062799
More Info
Key Skills
FDA engagement
IND submissions
Inspection readiness
Cross-border development programmes
Global regulatory strategy
Managing CROs and external regulatory partners
Regulatory operations and submissions
Due diligence and regulatory assessment
About Company
Skills:
cgmp manufacturing , Advanced Analytics, shopfloor management, GMP documentation, MES automation, inspection readiness, cross-functional issue resolution, deviation and CAPA delivery, Change Control, Operational Risk Management, Production Planning, AI-enabled solutions
Skills:
compliance advisory , AML CFT, Investigations, Compliance Risk Assessment, MAS 626, regulatory liaison, Manage People, Manage Projects, Compliance Policies and Standards, Manage Change, Manage Conduct, Compliance Review and FCC Assurance, Surveillance including Screening and Monitoring
Skills:
Corporate governance requirements, Commercial acumen, Stakeholder Management, BizFile, Corporate secretarial best practices, ICSA CGI qualification or equivalent professional qualification, CSP regulatory requirements, Cas, e-Stamping, Strong knowledge of the Singapore Companies Act, Compliance mindset, Risk management, Microsoft Office Applications
Skills:
Internal Risk Management, Chip Vault Controls, Cage Cash Management, Accounting, Finance, Business Administration, GRA AML Regulatory Compliance
Skills:
Cloud Security, Change Management, Application Security, Infrastructure Security, Security Assessments, Cybersecurity Engineering, Security Architecture, Security Management Systems, competitive advantage, managed security services, Security Technology, Regulatory Compliance, Risk and Compliance Management, Enterprise Security Solutions, Security Incident Response, coordinating audits