• location: Swiftwater, PA
  • type: Contract
  • salary: $42 - $49.41 per hour
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job description


Job Title: Regulatory Affairs Specialist II - CMC

Job Summary

  • Candidate to author CMC (Module 2.3 and 3) Common Technical Documents (CTDs) supporting an international, initial product registration at a minimum.
  • The candidate must have working knowledge of biologics (preferably viral vaccines) and regulations pertaining to pre and post licensure CMC activities.
  • Working knowledge must also include an understanding of ICH/ GMPs guidelines with EU regulatory experience regarded as a plus.
  • The candidate must be well-organized, work with minimal management and meet aggressive timelines.
  • Must utilize knowledge of word processing (software capabilities / functionality) and exhibit strong writing / analytical skills.
Education & Qualifications

  • BS / BA in Biology / Chemistry or related field
  • Experience: 3 to 6 years with regulatory experience in drug/biologics licensure (EU regulatory experience preferred) including CMC technical writing
  • CMC / Regulatory writing experience - minimum of 3 years authoring CMC documentation (CTDs)
  • Scientific background (vaccines preferred)
  • Microsoft Office (Word, Excel, Powerpoint, Visio, Outlook)
  • Electronic documentation file systems (Veeva Vault)
  • ICH / GMP guidelines
  • Experience with drug/biologics licensure (EU preferred)

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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