Jane Hart Email & Phone Number

Regulatory Affairs professional having an understanding of regulatory requirements and experience in Generic and Branded Products such as ANDAs (505(j)), NDAs -505 (b) (2), INDs, OTC and DMF submissions to FDA. Experienced in developing regulatory strategies to support product development, registration and lifecycle maintenance activities; Pre-Approval and Post-Approval submissions (PAS, CBE-30, CBE-0, and Annual Reports); the compilation of administrative information and Module 3 CMC documents in CTD format following ICH guidelines. Assisted with New Product Launch and supported Drug Development teams, reviewed and approved Advertising and Promotional Materials. Proven excellence in assessing change requests from a Regulatory perspective using quality systems to ensure high-quality submissions to FDA. Broad experience in OTC products understanding of guidelines GLP/cGMP regulations, USP requirements and FDA guidance. Organized, detail-oriented, self-motivated independent worker with excellent regulatory knowledge, written and verbal communication skills.

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  Regulatory Partner

  Vistaar

  Mar 2018 - Present - Princeton, New Jersey, Us

  Currently working as a Regulatory partner with VISTAAR

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  Northeastern University

  And Medical Devices