Director, Regulatory Affairs

New Jersey
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Director, Regulatory Affairs.  

Major tasks and responsibilities include:
  • Develops CMC regulatory submission strategies, reviews content, and maintains submission timelines to meet business objectives.
  • Proactively identifies regulatory issues and provides solutions to keep assigned programs on time and of high quality.
  • Leads efforts for coordinating CMC and overall content for original INDs, and IND amendments for inclusion in Clinical Trial Applications and NDAs.
  • Works with the CMC team on plans for NDA/MAA submissions and leads preparation.
  • Participates in multidisciplinary efforts to prepare updates for regulatory documents including Investigator Brochures, Annual Reports, IND, CTA and NDA submissions and background documents for Regulatory Authority meetings.
  • Works with multiple functional groups to prepare applications and respond to Health Authority queries in a timely fashion.
  • Establishes, manages, and maintains a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interprets and communicates relevant issues to colleagues.
  • Ensures communication and alignment on regulatory strategies through partnership and communication with internal key stakeholders.
  • Assures compliance with regulatory standards and guidance documents.
  • Prepares, submits, tracks, indexes, and archives electronic submissions.
  • Ensures that IND amendments, post-approval changes, annual reports, and CMC-related changes are reported to authorities in accordance with regulatory requirements.
  • Conducts risk assessments of global CMC regulatory issues.
  • Performs other duties as assigned.
We seek candidates with the following qualifications:
  • An advanced degree is required. A PhD is preferred.
  • Must have experience with NDA preparation and submission.
  • 10+ years of drug development and regulatory affairs experience in the Biotech/Pharmaceutical industry is required.
  • Requires experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development.
  • Must have demonstrated knowledge of regulatory aspects of small molecule Chemistry, Manufacturing and Controls.
  • Experience in Quality Assurance is a plus.
  • Experience with labeling requirements is a plus.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.
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