Senior Manager Regulatory CMC
Title: Senior Manager Regulatory CMC
The Senior Manager, Regulatory Affairs - CMC will play a key role within the Regulatory Affairs team, focusing on Chemistry, Manufacturing, and Controls (CMC) for drug-device combination products. This individual will lead regulatory strategy and documentation efforts, support cross-functional teams on product and process changes, and ensure compliance with global regulatory requirements. Responsibilities include managing submissions for new products and post-approval changes, overseeing periodic reporting obligations, and providing strategic guidance to project teams.
Responsibilities
- Develop and execute CMC regulatory strategies for combination products, including authoring and reviewing submissions (INDs, NDAs, DMFs, etc.) and related documentation (specifications, development reports, protocols, NCRs, CAPAs).
- Support creation and maintenance of labeling for new and marketed products, including prescribing information, instructions for use, and packaging components.
- Lead or participate in CMC-related change control processes; assess regulatory impact of post-approval changes and prepare required submissions.
- Manage preparation and submission of periodic reports to regulatory authorities.
- Collaborate with Quality and Regulatory leadership on field actions, recalls, and associated communications when necessary.
- Identify and implement process improvements to enhance efficiency and maintain compliance with evolving regulations.
Qualifications
- Bachelor's degree in a scientific discipline (Chemistry, Chemical Engineering, Pharmaceutical Sciences, etc.) with 7-10 years of experience in product development, manufacturing, CMC, Regulatory, or Quality. Advanced degree and/or cross-functional experience preferred.
- Strong knowledge of CMC regulatory requirements, FDA guidance, and global standards; experience with drug-device combination products is a plus.
- Proven experience preparing and reviewing regulatory submissions (INDs/CTAs, NDAs/MAAs, etc.).
- Familiarity with post-approval change assessments and GMP/GDP principles.
- Proficiency in project management tools and techniques for cross-functional deliverables.
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