Associate Director Global Regulatory CMC Cell Therapy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Functional Area Description

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes and provides guidance on regulatory expectations.

Position Summary / Objective

The CMC Regulatory Associate Director, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions. In this role, the GRS-CMC Associate Director, Cell Therapy will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Global Product Supply (GPS). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.

Position Responsibilities


Represent regulatory 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 oversite 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

Mange relationships with diverse teams

Utilize electronic systems for dossier creation and tracking.


Experience/Degree Requirements


Minimum BA/BS Degree and 7-10 years Pharmaceutical industry experience – prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 6 years CMC regulatory strategy (biologics/cell therapy experience preferred).

Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell therapy compounds preferred.

Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, 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, handle and prioritize multiple projects and work independently.

Ability to identify, communicate and resolve complex issues.

Prepare and manage filings and ensure thoroughness, accuracy and timeliness.

Ability to interpret global regulations and guidance.

Strong oral and written skills.

Proficient with electronic systems


Travel Requirements: 30%

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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