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Regulatory Operations Specialists

2 months ago

De Soto, United States AA2IT Full time
Title - Pharmaceutical Labeling Specialist
Location - DeSoto, KS (hybrid remote with 3 days onsite)
Duration - 18 months
Pay Rate - $26/hr
Responsibilities -
  • Prepare new/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 liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
  • Label review and submission of labeling documents and artwork
  • Quality check for label content and formatting as per FDA guidelines.
  • Support the team with the review, revising labeling.
  • Prepare the label content following SOP's and FDA regulations.
Qualifications -
  • ssociate degree minimum, Bachelor/Master's degree in Life Science preferred
  • Scientific background or familiarity with medical terminology
  • Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology experience preferred
  • Excellent proofreading skills
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook,SharePoint, and Adobe.
  • ttention to details.
  • Team Player.
  • ble to follow directions.
  • Can work independently once the trainings are complete.
  • ble to make sure that regulations are met.
  • Excellent communication and written skills.
  • Open minded.