The Regulatory Affairs Manager, CMC will support the initial registration of products and will be the lead for life cycle management of other products, including determining regulatory reporting, and global filing requirements for post-approval variations related to synthetics (small molecule) products. The Manager will also facilitate communication of requirements and strategy to Technical Transfer Team (TTT) in addition to the functional areas. The Manager will follow standard processes to drive consistency across post approval programs.
Serve as Regulatory CMC voice for Regulatory team by providing the following services:
- Define minimum regulatory filing requirements for post approval programs
- Provide regulatory strategy through development of marketing application strategic plan and/or events
- Global regulatory strategy
- Development of post approval variations including maintenance of applications
- Maintain product compliance through appropriate regulatory filings and activities
- Support Change Management activities
- Manage regulatory agency questions, commitments and periodic reports
- Facilitate agency interactions, including meeting preparation, meetings and briefing documents
- Ensure alignment with variation plans, develop global implementation requirements, and implement changes throughout product life-cycles
- Liaise with regional regulatory CMC counterparts and other functions within development, operations, supply chain and contract manufacturers to ensure alignment of global regulatory strategies, timing, execution and plans
- Monitor and, as necessary, provide data to be entered into tracking systems for department deliverable and ensure information is current
- Participate as an active member of cross-functional teams as needed
Preferred Qualifications
- Degree in Life Science
- Experience in Manufacture, Quality, Process Development or other related Pharmaceutical/Biotech industry
- Regulatory CMC experience with small molecule and Biologic products
- CMC-specific regulatory knowledge & experience
- 10 years+ of Regulatory CMC or related technical experience
