Senior Vice President, Regulatory Affairs Lead
8 hours ago
Vice President/Senior Vice President, Regulatory Affairs
*Based in New England or flexible to travel*
Key Responsibilities:- Provide strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments, leading the Regulatory Affairs group in hiring, mentoring, and staff management.
- Drive the planning and implementation of meetings with regulatory authorities, effectively representing the client's regulatory interactions.
- Direct and negotiate submissions (IND, CTA, BLA, MAA, etc.) and approvals with regulatory authorities.
- BS required, MS/PhD/PharmD preferred.
- 15+ years of Regulatory Affairs experience.
- Experience in virology/infectious disease required.
- Experience leading programs from Initial IND/CTA through BLA/MAA.
- Extensive Health Authority interaction experience (FDA, EMA, Health Canada).
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