Ambareen Sheriff

Head of Regulatory Services


Ms. Sheriff has lead U.S. EMEA, HC and ROW regulatory and quality strategies supporting development and preparation of drug products, investigational studies, and marketing authorization. She has received FDA and EMEA approval for over 50 products for numerous INDs, ANDAs, NDAs, and Supplements, and has extensive working knowledge of 21 CFR, DDMAC, cGMPs, ISO, ICH, EMA and USP regulations.

With more than 32 years of experience, Ms. Sheriff is an expert in regulatory strategies for orphan drug designation, exclusivity, controlled correspondences, briefing books, etc. In addition to the different types of applications for the FDA, she has submitted drug applications to EMA, Health Canada and Scientific advice packages to MHRA, EMA and Brazil as part of global regulatory strategy. She has strong international experience of product registrations to regulatory authorities such as EMA, CE mark, TGA & TPD.

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Core Competencies

  • CMC Regulatory Strategy
  • IND/BLA/NDA Authoring
  • Labeling
  • Formulation Background
  • Orphan Designation
  • Agency Type A & B Meetings
  • Briefing Books
  • Device/Drug Combo Products