CMC Regulatory Affairs Sr Mgr # JN -072021-67898

 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