What are the responsibilities and job description for the Senior Manager Regulatory Affairs CMC position at Meet Life Sciences?
MEET have partnered with one of our esteemed biotech clients focused in the rare disease space as they seek a tenured Senior Manager Regulatory Affairs CMC to join their wonderful team. Based in Rockville, MD they are looking at a hybrid model.
Responsibilities:
- Review source documents (batch records, stability data, validation reports, manufacturing changes, analytical test data, etc.)
- Author CMC module documents for supplements and annual reports
- Support and provide guidance on Regulatory CMC strategy for post-approval changes and life cycle management
- Foster a collaborative partnership between cross functional teams to support compliant CMC execution.
- May manage junior staff.
Knowledge & Experience:
- Extensive experience in Regulatory CMC, specifically with US FDA
- Expertise in post-approval variations/supplements in LCM
- Proficient in reviewing source documents (e.g., batch records, validation reports) and Module 2 & 3 documents
- Strong background in Small Molecules and collaboration with CMO/CDMO partners
- Skilled in Change Control processes
- Experienced in performing gap analysis
- Ability to work independently with high efficiency
