Senior Director, Regulatory Affairs

Responsibilities:
- Develop and execute integrated global regulatory strategies for investigational oncology assets through approval and lifecycle management (partner with VP, Regulatory Affairs).
- Serve as global regulatory lead for assigned programs; provide strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, Commercial).
- Lead planning, preparation, and submission of FDA regulatory documents (INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, NDA/BLAs); coordinate with external vendors for other regions.
- Plan, prepare, and lead health authority interactions (pre-IND, Type B/C, EOP, pre-submission meetings); coach cross-functional teams.
- Lead and manage a small US regulatory team; set priorities, allocate work, and build a collaborative, accountable culture.
- Anticipate regulatory risks across regions and design mitigation strategies; advise on regulatory implications of program decisions.
- Monitor and interpret global regulations, ICH guidelines, and oncology-specific policies; translate into actionable strategy.
- Partner with collaborators, CROs, regulatory consultants, and co-development partners to ensure efficient execution.
- Ensure compliance with global regulations and internal quality/SOP requirements; maintain audit-ready documentation and inspection readiness.

Qualifications:
- Bachelor’s degree in life sciences required; MS/PharmD/PhD/MD preferred.
- 10–12 years progressive regulatory affairs experience in biotech/pharma.
- Oncology/hematology regulatory experience required; track record across multiple phases.
- Experience leading global regulatory strategy with direct FDA and EMA engagement; additional ICH regions (e.g., PMDA, Health Canada) strongly preferred.
- Experience leading health authority meetings and major submissions (IND/CTA; ideally NDA/BLA/MAA).
- Experience managing in a cross-functional matrix; prior people management highly preferred.
- Deep knowledge of global regulatory requirements, ICH, oncology frameworks, and expedited pathways (Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug).
- Strong leadership, influencing, and project management; comfortable in fast-paced small biotech.
- Exceptional written/verbal communication; able to present/negotiating with authorities and senior stakeholders.
- Detail-oriented, highly organized; manage multiple priorities and deadlines.