CMC Regulatory Affairs Sr Mgr # JN -072021-67898

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Industry: Regulatory
Job Number:

 Description:

  • Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations
  • Interfaces with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity
  • Coordinate site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative
  • Serve as Regulatory CMC voice for product teams by providing the following services:
    • Define minimum regulatory filing requirements for post approval programs
    • Provide regulatory strategy through development of MASP and/or event GIRS
    • Development of post approval variations
    • Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
    • Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
    • Support Change Management activities as needed
    • Respond to regulatory agency questions
    • Facilitate agency interactions, including meeting preparation, meetings and briefing documents
    • Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
    • Contribute to the PDT’s Variation Master Plan as required
    • Participate as an active member of cross-functional teams

Knowledge and Skills

  • CMC- specific regulatory knowledge & experience
  • Understanding and application of principles, concepts, theories and standards of scientific/technical field

Education & Experience (Basic)

  • Doctorate degree and 2+ years of directly related experience

OR

  • Master’s degree and 3-5 years of directly related experience

OR

  • Bachelor’s degree and 6-8 years of directly related experience


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