Associate Director/Director, Regulatory Affairs
Description
About the Role
Late clinical-stage rare disease company preparing for NDA & global submissions and commercial readiness is seeking a Director/Senior Director, Regulatory Affairs to join as their second regulatory hire. Reporting to the VP of Regulatory Affairs, this individual will play a critical leadership role in shaping and executing global regulatory strategy across the US, EU, UK, and Japan. This is an execution-oriented and strategic position ideal for someone who thrives in small biotech environment and has successfully led global submissions for rare disease medicines. You will partner closely with the VP while owning major components of global strategy, submissions, and agency engagement. Key Responsibilities:
- Contribute to the development and execution of global regulatory strategy for the US, EU, UK, and Japan.
- Manage interactions with the UK MHRA for CTA submissions using IRAS Combined Review system (sub-IRAS).
- Lead the preparation, authoring, and review of major regulatory submissions, including NDA, MAA, and JNDA components.
- Support and, when appropriate, lead interactions with the FDA, EMA, and PMDA.
- Partner with external regulatory consultants, publishers, and regional agents to ensure high-quality deliverables aligned with the global regulatory strategy.
Position Requirements:
- Minimum of BS in Biology, Chemistry, or related discipline.
- 10+ years of regulatory affairs experience in the biopharmaceutical industry.
- Proven success leading global submissions (NDA + MAA).
- Deep expertise with MAA (Marketing Authorization Application) submissions.
- Experience managing day-to-day EU rare disease regulatory activities.
- Background as a GRL (Global Regulatory Lead) in Europe, or a US based regulatory leader with extensive firsthand UK/EU filing experience.
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