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Regulatory Affairs Specialist III
Ref No.: 19-06486
Location: Swiftwater, Pennsylvania
Be apart of a global biopharmaceutical company committed to healthcare solutions from prevention to treatment. Our client turns scientific discoveries into medicine to improve human health. Everyday they dedicate  the out most important resources for people to support patients and families through their health journey.

  • Candidate to author/review/approve CMC technical documents in internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities.
  • Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC.
  • Provide regulatory guidance for development projets, post-approval CMC changes/variations.
  • Must have working knowledge of GMPs. Must be well-organized, work with minimal management and meet aggressive timelines.
  • Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
  • **This position is working in the CMC area. Relevant experience is required
  • Experience with drug/biologics licensure, Prior regulatory experience
  • Technical writing experience (CMC experience )
  • Scientific background
  • CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3
  • Scientific background, vaccines preferred
  • Microsoft Office (word, excel, powerpoint)
  • Documentum/ Veeva Applications
  • Trackwise Applications
  • ICH Guidelines
  • GMP experience
  • Experience with drug/biologics licensure preferred
  • Prior regulatory experience
BS in Biology/Chemistry or related field