Regulatory Affairs Specialist

2 weeks 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.

Responsibilities:
  • Regulatory Compliance: Ensure compliance with regulatory requirements for biologicals labeling, including USDA submissions and maintenance of regulatory documents.
  • Labeling and Packaging: Prepare new and revised label packaging for regulatory submissions, working closely with internal stakeholders and regulated packaging processes.
  • Regulatory Filing: Support regulatory filing submissions with the USDA for domestic and international product packaging.
  • Collaboration: Work independently with internal stakeholders to revise or draft new packaging for vaccine biologicals, ensuring compliance with established regulations.
  • Documentation: Ensure prompt availability of labels and artworks, liaising with departments such as Marketing, Pharmacovigilance, and Technical Services.
Requirements:
  • Education: Associate's degree with 3-5 years of relevant experience, or Bachelor's degree with 0-3 years of experience, or Master's degree with 0-2 years of experience.
  • Experience: Minimum 3-5 years of relevant experience in pharmaceutical labeling, with a scientific background or familiarity with medical terminology.
  • Skills: Excellent proofreading skills, proficiency in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, and ADOBE.
  • Industry Knowledge: Preferred experience in the pharmaceutical industry, vaccine manufacturing, or medical and biotechnology.


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