Sr. Manager, Regulatory CMC
United States
Regulatory /
Remote /
Remote
Summary:
The Senior Manager, Regulatory CMC is responsible for representing regulatory CMC on large and small product teams supporting the Cullinan Therapeutics portfolio, including developing and implementing regulatory CMC strategies and activities in a global regulatory environment. In addition, this position prepares and reviews CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. This role will also provide significant input on establishing applicable processes, policies, procedures, and tools to facilitate effective execution by the Regulatory CMC function across the organization.
Position Responsibilities:
- Serve as Regulatory CMC lead and expert on large and small molecule product teams and provide expert interpretation of applicable ICH/FDA/EMA/global regulations to ensure compliance with regulatory requirements.
- Define and implement regulatory CMC strategies and priorities for clinical trial and registration applications/amendments, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with stakeholders.
- Lead and manage preparation of high-quality regulatory CMC submission content, e.g., briefing books, quality modules for clinical trial and marketing applications, drug master files, responses to regulatory authority inquiries, etc.) to support global clinical development, registration, and product life cycle management.
- Manage regulatory CMC compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, CCs, etc.
- Provide regulatory CMC leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, as well as on product and compliance quality initiatives.
- Interact with colleagues in other departments, other R&D functions, and RA functions to deliver high quality dossiers, documents, and materials in accordance with business priorities.
- Support Regulatory Information Management (RIM) by ensuring efficiency, traceability and compliance of regulatory CMC information and documents in Veeva Vault RIM.
- Actively lead/participate in regulatory CMC infrastructure and capability building, including establishing and optimizing processes, best practices, templates, training tools, and cross-program learning.
Candidate Requirements:
- BA/BS in life sciences, Chemistry, Biology, or other scientific discipline; advanced scientific degree strongly preferred.
- 5+ years industry experience in biotech or pharma with at least 3 years’ experience directly in a Regulatory CMC role or role with Regulatory CMC submission responsibilities.
- Technical expertise and knowledge of the regulatory CMC requirements for GxP compliance and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance.
- Strong understanding of CMC requirements for regulatory submissions with direct experience in authoring CMC dossiers for IND/IMPD and BLA/NDA/MAA.
- Ability to apply practical scientific understanding of CMC areas and translate complex scientific/technical content into concise written documents and presentations.
- Experience with global regulatory aspects of CMC across large and small molecule programs involving undefined frameworks with technical complexity and broad scope.
- Demonstrated ability to work effectively both independently and in a collaborative/team environment, with the flexibility and strength to navigate high-stress situations with multiple disciplines and personalities.
- Strong written and oral communication and organizational skills, including ability to prioritize work tasks across multiple projects and timelines. Demonstrated ability to manage competing priorities to deliver on-time and high-quality regulatory CMC documents.
- Experience with document management and Regulatory Information Management (RIM). Veeva Vault experience preferred.
- Proficient with MS Office tools to perform project management, tracking, writing and presentation tasks.
