CMC Regulatory Affairs Sr Mgr # JN -072021-67898
,
Posted on: July 30, 2021
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