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Regulatory Affairs Specialist III
Ref No.: 19-07624
Location: Swiftwater, Pennsylvania
Join a global biopharmaceutical company committed to healthcare solutions from prevention to treatment.  They turn scientific discoveries into medicine to improve human health.  Every day they dedicate their most important resource, the people, to support patients and families through their health journey.


Duties:
  • Candidate to author/review/approve CMC technical documents in ***’s 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 )

Skills:
  • 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
Education:
BS in Biology/Chemistry or related field