Regulatory Affairs Specialist for Biologicals Labeling

1 week ago


South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time
Job Title: Regulatory Affairs Biologicals Labeling Specialist

Katalyst Healthcares & Life Sciences is seeking a highly skilled Regulatory Affairs Biologicals Labeling Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for preparing new and revised label packaging for regulatory submissions to the USDA and maintaining regulatory documents to ensure site compliance.

Responsibilities:
  • Prepare new and revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
  • Support regulatory filing submissions with the USDA for both domestic and international product packaging.
  • Independently work with internal stakeholders, regulated packaging processes, and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets.
  • Ensure prompt availability of labels and artworks and liaise with departments such as Marketing, Pharmacovigilance, and Technical Services to ensure compliance with established regulations.
Requirements:
  • With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience.
  • With Bachelor's, minimum 0-3 years of relevant experience within pharmaceutical labeling experience.
  • With master's minimum 0-2 year of relevant experience within pharmaceutical labeling experience.
  • Require someone with scientific background or familiarity with medical terminology.
  • Require someone with excellent proofreading skills.
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, ADOBE.
  • Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology.


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