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Associate Director, Global Regulatory Sciences - CMC, Uxbridge
Client:
Bristol Myers Squibb
Location:
Uxbridge, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
8d2b3ef7ac75
Job Views:
3
Posted:
02.06.2025
Expiry Date:
17.07.2025
Job Description:
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
* Represent regulatory CMC on or lead matrix teams for small molecule pipeline and/or commercial products through post-marketing and lifecycle management projects.
* Provide strategic guidance on regulatory requirements and expectations for marketing applications, clinical trial applications, and lifecycle changes.
* Manage multiple complex projects independently.
* Interface with Health Authorities for CMC submissions and issues, with guidance from supervisors for complex topics.
* Identify, communicate, and propose solutions to routine and complex issues.
* Interpret global regulations and identify regulatory 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 thoroughness, accuracy, and timeliness, including strategy documentation.
* Manage relationships with diverse teams and utilize electronic systems for dossier creation and tracking.
Requirements
* 7-10+ years of pharmaceutical industry experience, including 6+ years in CMC regulatory strategy.
* Knowledge of CMC regulatory requirements during development and post-approval for small molecule products.
* Understanding of pharmaceutical development processes, including drug substance, drug product, and analytical methods.
* Ability to build strong working relationships with regulatory and cross-functional teams, lead multifunctional teams, and handle multiple projects independently.
* Skill in identifying, communicating, and resolving complex issues.
* Experience in preparing and managing regulatory filings with accuracy and timeliness.
* Ability to interpret global regulations and guidance.
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.
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