Global Regulatory Sciences Expert for Cell Therapy
3 days ago
Transforming patients' lives through science is a vision that inspires every Bristol Myers Squibb employee. As a GRS-CMC Cell Therapy Associate Director, you will play an integral role in this mission by applying your individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials.
Key Responsibilities:- Represent the Global Regulatory Sciences organization on matrix teams for Cell Therapy pipeline products and/or commercial products, driving completion of post-marketing commitments and relevant lifecycle management projects.
- Provide strategic guidance/input related to current regulatory requirements and expectations for cell therapy marketing applications, clinical trial applications, and/or lifecycle changes to marketed products.
- Independently manage and prioritize multiple complex projects, ensuring timely submission of CMC documents to global markets.
- Interface with Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics.
- Identify, communicate, and propose resolutions to routine/complex issues, leveraging knowledge of global CMC regulatory requirements during development and post-approval.
- Minimum BA/BS Degree
- 7-10+ years pharmaceutical industry experience across multiple disciplines, with 6+ years CMC regulatory strategy experience for biologic/cell therapy products 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, and handle and prioritize multiple projects and work independently.
- Ability to interpret global regulations and guidance, identify regulatory opportunities and risks, and anticipate possible regulatory paradigm shifts.
We offer a competitive salary range estimated between $150,000 - $250,000 per year, depending on location and qualifications. Additionally, we provide comprehensive benefits, including medical, dental, and vision coverage, as well as a 401(k) matching program.
About Us:Bristol Myers Squibb is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe Associate Director for Global Regulatory Sciences Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding clinical trial applications, new marketing applications, Health Authority responses and background packages, and...
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe 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 ResponsibilitiesRepresent GRS-CMC on matrix teams for...
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