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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: a8720946fb6c
Job Views: 11
Posted: 28.04.2025
Expiry Date: 12.06.2025
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 CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.
Position Summary / Objective
The GRS-CMC Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions supporting biologics products, including clinical trial and marketing applications, HA responses, background packages, and post-approval submissions. They serve as the primary interface between GRS and GPS, assessing manufacturing change controls for global impact and guiding technical teams on global change management.
Position Responsibilities
* Represent regulatory CMC on matrix teams for pipeline and commercial products through post-marketing lifecycle management.
* Provide strategic guidance on regulatory requirements for small molecule applications and lifecycle changes.
* Manage multiple complex projects independently.
* Interface with Health Authorities for CMC submissions and issues, with guidance from supervisors.
* Identify, communicate, and resolve routine and complex issues.
* Interpret global regulations and identify opportunities and risks.
* Participate in product fact-finding meetings.
* Review and assess change controls.
* Prepare and manage CMC submissions globally, ensuring completeness and timeliness.
* Manage relationships with cross-functional teams.
* Utilize electronic systems for dossier creation and tracking.
Degree and Experience 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 molecules.
* Understanding of pharmaceutical development processes.
* Ability to develop and maintain strong cross-functional relationships.
* Proven ability to handle multiple projects and resolve complex issues.
* Experience with regulatory filings, global regulations, and guidance interpretation.
Key Competency Requirements
Strong oral and written communication skills, proficiency with electronic systems.
Additional Information
Details about onsite protocol, accommodations, vaccination policy, and equal opportunity statements are included to inform applicants about work arrangements and company policies.
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