Regulatory Operations Specialist

4 weeks ago


Rahway, United States Integrated Resources Full time
Job Title: Regulatory Operations Specialist
Job Location: Rahway, NJ
Job Duration: 12+Months

Shift: Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
 
Job Description:
  • Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
  • Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
  • Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
  • Maintain databases and team sites by ensuring updated and accurate information is uploaded.
 
Educational Qualification:
Associate/Bachelor of Life Science/Master's degree.
 
Required Experience and Skills:
  • With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience
  • With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience
  • With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience
  • Require someone with scientific background or familiarity with medical terminology.
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint.
  • Excellent English oral and written communication skills and presentation skills.
  • Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
 
Note:
• 1 year assignment with possibility of extension
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
• Manager will prefer someone with experience over a degree/education.

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