Director, Regulatory Affairs

Seeking a Director of Regulatory Affairs for our client – one of the largest specialty pharmaceutical companies in the United States.

This position is responsible for providing regulatory leadership for products in development through NDA approval as well as post-approval/life cycle management. Additionally, this role is responsible for ensuring high quality submissions are made to the FDA by leading, directing, planning, writing, and reviewing all regulatory submissions.

Direct Hire. Hyrbid Role; at least 3 days a week onsite


  • Develops and implements submission strategies for IND and NDA applications
  • Leads the planning, writing and review of all regulatory submissions to support pre-IND, original IND, 505(b)1&2 NDAs including FDA meeting requests and packages
  • Leads and actively participates in meetings with the FDA and other Health Authorities, as required
  • Critically reviews and approves reports and protocols from Clinical Development and documentation from Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments and internal stakeholders
  • Represents Regulatory Affairs on project teams and provides regulatory advice (non-CMC) to internal and external customers
  • Keeps up to date on FDA and International Council on Harmonisation (ICH) guidances and interprets/informs project teams of implications to drug development
  • Creates and manages project timelines; evaluates changes to maintain submission goals and timelines; Establishes good working relationships and manage relationships with internal and external partners
  • Provides feedback and coaching to others in the Regulatory Affairs Department
  • Manages, coaches and mentors direct reports



  • MS degree in a science field with 8 years of Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility OR BS degree in a science field and 9 years of Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility
  • Hands-on experience or support in multiple strategic and operational facets of pharmaceutical development
  • Thorough, working knowledge and understanding of small molecule development process
  • Proven track record of successful product filings in the pharmaceutical industry
  • Recent experience drafting documentation for regulatory applications
  • Proven record of developing and maintaining successful working relationships with the FDA
  • Demonstrated understanding of the regulatory process and technical competence in core areas of drug development
  • Ability to analyze and interpret scientific data and regulatory guidelines
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