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Associate Director, Global Regulatory Sciences Cell Therapy Lead
1 month ago
Job Summary
The Global Regulatory Sciences – Chemistry, Manufacturing and Controls (GRS-CMC) organization provides regulatory expertise related to 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. You will also perform regulatory assessments for manufacturing changes, provide guidance on regulatory expectations for medical devices, and provide compliance documents to support Health Authority submissions.
Key Responsibilities
- Represent GRS-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 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 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 mission is to discover, develop, and deliver innovative medicines that make a meaningful difference in the lives of patients. We are committed to advancing the field of cell therapy and developing new treatments for patients with complex diseases.
On-site Protocol
Bristol Myers Squibb has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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