Vice President/Senior Vice President, Regulatory Affairs
*Candidates should be based in New England or must be flexible to travel*
Key Responsibilities
- You will provide regulatory leadership and provide strategic direction to Regulatory Affairs, Clinical Quality, Medical Writing departments and lead Regulatory Affairs group, including hiring, mentoring, and leading staff
- Drive the planning and implementation of meetings with regulatory authorities and effectively represent the client's regulatory interactions
- Direct and negotiate submissions (IND, CTA, BLA, MAA etc..) and approvals with regulatory authorities
Key Qualifications
- 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)