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Director Regulatory CMC - Cell Therapy, Uxbridge
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Client:
Bristol Myers Squibb
Location:
Uxbridge, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
21d24f777c63
Job Views:
10
Posted:
28.04.2025
Expiry Date:
12.06.2025
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Job Description:
Description
The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members develop global regulatory CMC strategies and collaborate with stakeholders to implement them, ensuring alignment with business priorities. The team performs regulatory assessments for manufacturing changes, offers guidance on regulatory expectations for medical devices, oversees BSE programs, and provides compliance documentation for Health Authority submissions. They also support Medical Information by maintaining a database to address external inquiries regarding drug products.
Position Summary
The CMC Regulatory Director, Cell Therapy, is responsible for developing, maintaining, and reviewing the Quality Module for regulatory submissions related to Cell Therapy products, including clinical trial applications, marketing applications, Health Authority responses, and post-approval submissions. The director acts as the primary interface between Global Regulatory Sciences and Cell Therapy Development Operations, assessing manufacturing change controls for global impact and guiding technical teams on change management.
Position Responsibilities
* Represent regulatory CMC on or lead matrix teams for cell therapy pipeline and/or commercial products through post-marketing commitments and lifecycle management projects.
* Provide strategic guidance on regulatory requirements for biologics and cell therapy marketing and clinical trial applications.
* Manage and prioritize multiple complex projects independently.
* Interface with Health Authorities for CMC submissions and issues, with guidance from supervisors on complex topics.
* Identify, communicate, and propose solutions to routine and complex issues.
* Interpret global regulations and guidance, identifying opportunities and risks.
* Participate in product fact-finding meetings.
* Review and assess change controls from a regulatory perspective.
* Prepare and manage CMC submissions globally, ensuring completeness and timeliness, and develop strategy documents.
* Manage relationships with diverse teams.
* Utilize electronic systems for dossier creation and tracking.
Requirements
* Minimum of 10+ years in the pharmaceutical industry, with preferred experience in biotechnology and cell therapy products, including at least 8+ years in CMC regulatory strategy (biologics/cell therapy experience preferred).
* Knowledge of CMC regulatory requirements during development and post-approval, with experience in global regulations for biological/cell therapy products preferred.
* Understanding of biopharmaceutical development, including biological drug substances, sterile drug products, and analytical methods, with expertise in cell therapy drug development and analytical methods preferred.
* Proven ability to develop and maintain strong working relationships within regulatory CMC teams and cross-functional teams, handle multiple projects, and work independently.
* Ability to identify, communicate, and resolve complex issues.
* Experience in preparing and managing regulatory filings thoroughly, accurately, and timely.
* Ability to interpret global regulations and guidance.
* Strong oral and written communication skills.
* Proficiency with electronic systems.
Uniquely Interesting Work, Life-changing Careers
With a vision to “Transforming patients’ lives through science,” every BMS employee plays a vital role in impactful work. We empower individuals to apply their talents and perspectives in an inclusive culture that promotes diversity in clinical trials. Our shared values—passion, innovation, urgency, accountability, inclusion, and integrity—bring out the best in our colleagues.
On-site Protocol
BMS has a diverse occupancy model determining where employees work, including site-essential, site-by-design, field-based, and remote roles. Site-essential roles require 100% onsite presence; site-by-design roles may allow hybrid work with at least 50% onsite; field-based and remote roles require travel and attendance at meetings as directed.
BMS is committed to supporting people with disabilities through accommodations and ongoing support. Applicants can request accommodations during the application process. For more information, visit our website and review our Equal Employment Opportunity statement.
We prioritize health and safety; therefore, vaccination against Covid-19 and boosters are strongly recommended for all employees.
BMS considers qualified applicants with arrest and conviction records, in accordance with applicable laws.
All data processed during the application will be handled in accordance with privacy policies and regulations.
Bristol Myers Squibb is Disability Confident – Committed
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