Regulatory Sciences Associate Director Cell Therapy
4 weeks ago
Job Summary
The Global Regulatory Sciences organization provides regulatory expertise related to Chemistry, Manufacturing and Controls (CMC) activities through all stages of a product's lifecycle. As a key member of the team, you will develop global regulatory CMC strategies and partner with stakeholders to execute the strategies in alignment with business priorities.
Key Responsibilities
- Represent GRS-CMC on matrix teams for Cell Therapy pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research.
- Provide strategic guidance/input related to current regulatory requirements and expectation for cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
- Manage and prioritize multiple complex projects.
- 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.
- 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.
- Manage relationships with diverse teams.
- Utilize electronic systems for dossier creation and tracking.
Qualifications & Experience
Minimum BA/BS Degree
- 7-10+ years pharmaceutical industry experience across multiple disciplines. 6+ years CMC regulatory strategy experience for biologic/cell therapy products is preferred.
- Knowledge of global CMC regulatory requirements during development and post-approval. Expertise in cell therapy drug development process and analytical methods is 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 identify, communicate and resolve complex issues.
- Ability to interpret global regulations and guidance.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our employees are empowered to apply their individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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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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