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Katalyst Healthcares and Life Sciences

Regulatory Affairs Specialist

Katalyst Healthcares and Life Sciences, San Mateo

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Responsibilities:
  • Prepare drug listings and lot distribution reports for biologics.
  • Compile documentation and send certificate of pharmaceutical product requests to the FDA
  • Manage notarizations and legalization/apostille of regulatory documents.
  • ssist with documentation and signature preparation for license renewals and establishment registration.
Requirements:
  • Bachelor's degree in a relevant scientific field or equivalent experience in a GMP environment
  • 5 years of relevant training or industry experience preferably in a GMP environment.
  • Strong computer and organizational skills required.
  • Excellent verbal and written communication skills and interpersonal skills are essential.