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Director of Regulatory Affairs

Scientific Search
Princeton, NJ
  • Posted: December 02, 2022
  • Full-Time
Location: Ewing, NJ (Hybrid Schedule - Onsite for critical meetings)


Our publicly traded biopharma client with offices in NJ, California and the Midwest has tasked Scientific Search with finding them a Director of Regulatory Affairs. This is a position for an independent, proactive, regulatory affairs professional who has demonstrated leadership ability in the management of Regulatory Programs and Documents.


Responsibilities


  • The position holder prepares and/or reviews documents, and planning and production of regulatory dossiers
  • Responsible for collection, preparation and assembly of documentation required for the submission of product registrations, new drug applications, supplements, amendments, and routine reporting (e.g. Annual Reports and periodic adverse experience reports)
  • Provide strategic regulatory leadership and guidance to project teams and design programs for, but not limited to, INDs/CTAs, NDAs, and ANDAs.
  • Proactively identifies potential regulatory issues and recommends solutions to Regulatory Affairs management
  • Develops timeline for responding to inquiries from regulatory agencies and ensures issues are addressed in a timely manner


Requirements


  • BS degree in science (advanced degree preferred) or equivalent qualification and experience (preferably >7 years) in regulatory
  • Minimum of 5 years of regulatory experience in pharmaceutical and medical device industry
  • Substantial experience preparing a range of summary submission documents including clinical, non-clinical and chemistry content. Accurate and detail-oriented, with excellent interpersonal skills
  • Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, chemistry, manufacturing, and control (CMC), the regulatory environment, project management, and medical terminology
  • Must have prior experience in the preparation of NDA eCTD documentation
  • Must be fully conversant with U.S. Federal Regulations and Guidance governing the drug development and submissions process


For immediate consideration please email Kevin Wasser, at Kevin@Scientificsearch.com


Be sure to check out all of our other current openings at www.scientificsearch.com


Scientific Search

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