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Regulatory Affairs Director

2 months ago

Waltham, Massachusetts, United States Meet Full time
Regulatory Affairs Leadership Opportunity

We are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.

Key Responsibilities:

  • Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments
  • Drive planning and implementation of meetings with regulatory authorities and represent the company's regulatory interactions
  • Direct and negotiate submissions (IND, CTA, BLA, MAA, etc.) and approvals with regulatory authorities

Requirements:

  • 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)

What We Offer:

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive compensation and benefits package