CMC Regulatory Director for Cell Therapy
1 week ago
Job Summary
The CMC Regulatory Director for Cell Therapy will be responsible for developing and implementing global CMC regulatory strategies for cell therapy products. This includes content development, compilation, maintenance, and review of the Quality Module for regulatory submissions.
Key Responsibilities
- Represent regulatory CMC on and/or lead matrix teams for cell therapy pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research
- Independently provide strategic guidance/input related to current regulatory requirements and expectation for biologics/cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
- Independently manage and prioritize multiple complex projects
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Identify, communicate and propose resolutions to routine/complex issues
- Interpret global regulations and guidance. Identify regulatory opportunity and risks.
- Anticipate and communicate possible regulatory paradigm shifts
- Participate in product fact finding meetings
- Review and provide regulatory assessments on change controls
- Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
- Mange relationships with diverse teams
- Utilize electronic systems for dossier creation and tracking.
Requirements
- Minimum BA/BS Degree
- Minimum of 10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 8+ years CMC regulatory strategy (biologics/cell therapy experience preferred).
- Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell therapy compounds preferred.
- Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, preferred.
- Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
- Ability to identify, communicate and resolve complex issues.
- Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
- Ability to interpret global regulations and guidance.
- Strong oral and written skills.
- Proficient with electronic systems
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our mission is to discover, develop, and deliver innovative medicines that help patients overcome some of the most challenging diseases of our time. We are committed to making a positive impact on the lives of patients, families, and communities around the world.
Equal Employment Opportunity
Bristol Myers Squibb is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and diverse workplace where everyone has the opportunity to succeed. We are proud to be a Disability Confident employer and are committed to providing reasonable accommodations to qualified individuals with disabilities.
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