Director, Regulatory Affairs

Hybrid Opportunity - 2-3x per week onsite in South San Francisco, CA

Meet has partnered with a clinical-stage, pre-IPO biotech focused in treatments for rare hematology/oncology indications. They are looking for a Director of Regulatory Affairs to join their team!

Key Responsibilities

• You will report into the SVP of Regulatory Affairs and will provide regulatory guidance/support for multiple clinical-stage programs.
• You will work with cross-functional leaders to support the planning and preparation of Phase III protocols and BLA submissions.
• You will work with CRO's/consultants in ex-US countries (EU/UK) in support of CTA and MAA preparation

Key Qualifications

• 8+ years of pharmaceutical regulatory affairs experience required
• Experience in hematology/oncology/autoimmunity highly preferred
• Leading programs from Phase I through NDA/BLA submission highly preferred
• Experience liaising with EMA/MHRA to facilitate CTA/MAA submissions preferred

Please reach out to Ryan Moran for more information:

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