Regulatory

  • location: King Of Prussia, PA
  • type: Contract
  • salary: $50 - $58.91 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/296507

Job Title: CMC Regulatory Manager

Job Summary

  • The scope of the work is to partner with CMC Regulatory Affairs personnel by reviewing historical CMC registered files (BLAs/supplements/amendments) and authoring/compiling compliant CTD formatted documents within project timelines and with limited oversight.

Education & Qualifications

  • Minimum of a Bachelor's degree in a scientific discipline plus 3 or more years of CMC experience with for FDA-regulated biologics (small molecule experience will also be considered).
  • Understanding of US regulations and regulatory expectations for biologics.
  • Understanding of biologics manufacturing and analytical methods.
  • Background in a functional discipline related to biologics CMC a plus (cell banking, upstream or downstream operations, secondary manufacturing, validation, analytical testing, etc)
  • Experience in the critical review of submissions for content, quality and compliance
  • Experience with technical writing of CMC documents
  • Experience with documentum and the aptitude to learn various IT systems as they relate to training, document creation, formatting, publishing activities, etc.
  • In additional the candidate must be fluent in English, detail oriented.
  • Must be flexible in terms of changing priorities and deadlines, as well as possess the interpersonal skill to work in a matrix team environment.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296507

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