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Sr Manager QC Documentation - Regulatory (Cambridge, MA)

Location: Cambridge, Massachusetts Salary: competitive
Sector: Pharma & Biotech, Regulatory Affairs, Regulatory Affairs (RA) Type: Contract

Our client in Cambridge, MA is seeking a Sr Manager with experience working with QC Documentation, specifically in regards to Regulatory Documentation.

OBJECTIVES:

  • Lead documentation preparation for regulatory submissions (CMC sections for BLA/MAA/NDA, briefing books, responses to questions from Health Authorities). Responsible for delivery of high quality submission-ready documentation.
  • Serve as a technical writing and editing expert to team members and manage continuous process improvements. Ensure submission's compliance with regulatory requirements and internal quality standards.
  • Lead analytical/QC activities during the technology transfer and qualification of new manufacturing sites. Review and approve validation documentation; assure high quality of generated results and data integrity.
  • Partner with GRA CMC, Tech Operations and Supply Operations groups to ensure high quality and timely delivery of submission ready documentation.

ACCOUNTABILITIES:

  • Lead preparation of CMC sections in CTD format for new submissions and post-approval changes.
  • Lead compilation of responses to questions from Health Authorities. Provide technical expertise for CMC-related questions.
  • Review validation documentation, study protocols and reports to maintain compliance and assure high quality of generated data.
  • Oversee testing for process validation activities at multiple CROs, as applicable.
  • Assure collaborative, proactive, and effective communication with internal teams and external vendors and partners.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • Bachelors Degree in any Life Sciences and 10+ years of relevant experience or Master's Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience.
  • Ability to handle multiple tasks concurrently and in a timely fashion.
  • Good knowledge and familiarity with technical writing requirements.
  • Understanding of CMC regulatory requirements across major markets.
  • Experience with small molecule and biologic products.
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment.
  • Excellent written, oral and presentation communication skills in English.

Sthree US is acting as an Employment Business in relation to this vacancy.