Regulatory Sciences Director for Cell Therapy Products
2 weeks ago
Job Summary
The Global Regulatory Sciences Cell Therapy Associate Director is responsible for developing and executing regulatory strategies for Cell Therapy products. This role requires expertise in global CMC regulatory requirements, cell therapy drug development processes, and analytical methods.
Key Responsibilities
- Represent GRS-CMC on matrix teams for Cell Therapy pipeline products and commercial products through completion of post-marketing commitments and lifecycle management projects.
- Provide strategic guidance on current regulatory requirements and expectations for Cell Therapy marketing applications, clinical trial applications, and lifecycle changes.
- Manage and prioritize multiple complex projects, including CMC submissions and CMC-related issues.
- Interface with Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor.
- Identify, communicate, and propose resolutions to routine and complex issues.
- Interpret global regulations and guidance, identify regulatory opportunities and risks, and anticipate regulatory paradigm shifts.
- Participate in product fact-finding meetings, review and provide regulatory assessments on change controls, and prepare and manage CMC submissions for all global markets.
- Manage relationships with diverse teams and utilize electronic systems for dossier creation and tracking.
Qualifications & Experience
The ideal candidate possesses a minimum of 7-10 years of pharmaceutical industry experience, with 6+ years of CMC regulatory strategy experience for biologic/cell therapy products. Strong knowledge of global CMC regulatory requirements, cell therapy drug development processes, and analytical methods is required.
About Us
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to innovation, diversity, and inclusion, and strive to create a culture that promotes collaboration, productivity, and a positive company culture.
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