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A leading company in the pharmaceutical industry is seeking an Associate Director for Global Regulatory Sciences in Uxbridge. This pivotal role involves strategic guidance in regulatory submissions and managing complex projects, requiring substantial experience in CMC regulatory strategy and a deep understanding of pharmaceutical development processes.
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Bristol Myers Squibb
Uxbridge, United Kingdom
Other
Yes
8d2b3ef7ac75
3
02.06.2025
17.07.2025
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 execute these strategies aligned with business priorities. The team performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE programs, and supports Health Authority submissions. They also support Medical Information by maintaining databases to address external questions regarding drug products.
The CMC Regulatory Associate Director, Biologics, is responsible for developing, compiling, maintaining, and reviewing the Quality Module for regulatory submissions related to biologics products. This includes clinical trial applications, new marketing applications, health authority responses, background packages, and post-approval submissions. The role serves as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS), assessing manufacturing change controls for global impact and guiding technical teams on change management.
Responsibilities
Requirements
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 promote diversity and inclusion, especially in clinical trials, and uphold values of passion, innovation, urgency, accountability, inclusion, and integrity to maximize each colleague’s potential.
On-site Protocol
BMS has a flexible occupancy structure, including site-essential, site-by-design, field-based, and remote roles. Onsite presence requirements vary by role, with some roles requiring 100% onsite, others hybrid, and some field-based or remote. We are committed to supporting employees with disabilities through accommodations and support. Applicants can request accommodations during the application process. We also recommend vaccination for COVID-19 and boosters. BMS considers qualified applicants with arrest and conviction records, complying with applicable laws. All data processed will be handled per privacy policies and regulations.