SVP, Regulatory Affairs

2 months ago


Waltham, United States Meet Full time

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)


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