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Regulatory Affairs Specialist

1 month ago

San Mateo, California, United States Fladger Assoc. Inc. Full time
Job Overview

Fladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs Associate to join our team in Foster City, CA. This is a contract position with a duration of 12-18 months and a negotiable rate.

Key Responsibilities:

  • Prepare Drug Listings/Lot Distribution Reports (Biologics) and compile documentation for Certificate of Pharmaceutical Product (CPP) requests to FDA.
  • Manage Notarizations, Legalization/apostille of regulatory documents, and assist in documentation and signature preparation for license renewals and establishment registration.
  • Perform document filing and retrieval functions, and participate in preparing regulatory submissions under the direction of a senior Regulatory Affairs Professional.
  • Develop and acquire required regulatory skills and knowledge, and assist with miscellaneous US RA CMC team-related administrative documents/activities.

Requirements:

  • A Bachelor's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, or 1+ years relevant training or industry experience preferably in GMP environment with an advanced degree.
  • Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area.
  • Strong computer and organizational skills, excellent verbal and written communication skills, and interpersonal skills are required.