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CMC Regulatory Affairs Sr Mgr

Thousand Oaks, CA

Top 3 Must Have Skill Sets:    

CMC experience and regulatory affairs background required
*Manufacturing or quality background nice to have

Description:

***Remote candidates considered***

- 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:
o Define minimum regulatory filing requirements for post approval programs
o Provide regulatory strategy through development of MASP and/or event GIRS
o Development of post approval variations
o Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
o Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
o Support Change Management activities as needed
o Respond to regulatory agency questions
o 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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