Top 3 Must Have Skill Sets:
Superior written and verbal communication skills
Ability to digest complicated changes and drill down to the key problem statement
Understand risk based decision making and recommend best solution(s) to management
***Remote candidates considered***
Job Details: This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
- Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations, with specific emphasis on raw material and component changes.
- 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
Education & Experience (Basic)
Doctorate degree and 1+ years of directly related experience
Master’s degree and 2 years of directly related experience
Bachelor’s degree and 5 years of directly related experience
"This posting is for Contingent Worker, not an FTE"