Director, Regulatory CMC – Cell Therapy

Bristol Myers Squibb

. Oversee management of multiple development and life-cycle management projects of varying priorities and complexities .

Posted 10/2/2026full-timeUnited StatesLead💰 $215,940 - $299,287 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory CMC management, including the development and execution of global regulatory strategies for advanced therapies and cell therapy products. Proven ability to lead cross-functional teams, engage with health authorities, and ensure compliance with regulatory guidelines.

Highest-signal resume keywords

Regulatory CMC ExperiencePharmaceutical Development KnowledgeGlobal Regulatory Strategy DevelopmentCross-Functional Team LeadershipHealth Authority Engagement

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Applicant Tracking System Keywords

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Hard Skills

CMC Submissions PreparationAnalytical Methods KnowledgeRegulatory Compliance OversightIssue Resolution with Regulatory AuthoritiesStrategic Direction Development

Soft Skills

Relationship BuildingNegotiationConflict ManagementInfluencing OthersFacilitation

Tools & Technologies

Regulatory Information Management SystemElectronic Systems for Dossier Creation

Industry Keywords

Advanced TherapiesCell TherapyBiologic ProductsRegulatory GuidelinesPharmaceutical Industry

About the role

Key responsibilities & impact

Oversee management of multiple development and life-cycle management projects of varying priorities and complexities
Represent GRS-CMC on cross-functional teams, governance committees, and due diligence/in-licensing projects
Represent BMS at Health Authority meetings
Serve as a credible spokesperson with key stakeholders and Health Authorities
Develop and communicate strategic direction based on global regulatory guidelines and experience
Seek opportunities for external regulatory engagement for themselves and/or team members
Prepare or oversee preparation of CMC submissions, ensuring thoroughness, completeness, and timeliness
Review CMC Lead submissions for clarity of strategic and technical content
Utilize electronic systems for dossier creation, review, and tracking
Manage and actively support the growth and development of direct reports
Participate in leadership and department meetings
Anticipate and communicate possible regulatory paradigm shifts
Participate in product fact-finding meetings and R&D forums representing GRS-CMC
Support preparation of CMC policies and procedures
Maintain oversight and promote regulatory compliance through timely and accurate data entry into the Regulatory Information Management system

Requirements

What you’ll need

Minimum BA/BS Degree
Minimum 10 years pharmaceutical or related experience
8+ years regulatory CMC experience
Knowledge of CMC regulatory requirements for advanced therapies and/or cell therapy during development and post-approval
Knowledge of pharmaceutical development, including biologic and cell therapy upstream and downstream processes, analytical methods, and cell therapy products
Ability to develop and maintain strong working relationships and participate in or lead multifunctional teams
Ability to interact with CMC technical experts regarding process development and analytical issues
Proven success delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration
Experience leading cross-functional teams and driving quality decision-making
Ability to negotiate, influence others, facilitate issue resolution, and manage conflict
Direct experience developing strategy and leading teams through interactions with health authorities
Track record of issue resolution with main regulatory authorities
Strong understanding of policies, laws, regulations, and guidelines applying to global regulatory agencies
Experience communicating regulatory strategy, issues, and risks to senior leadership and governing bodies
Experience as a member of a CMC Team, GRTs, project working groups, or comparable experience
Experience developing strategy for product partnerships, including out-licensing, divestiture, co-development, in-licensing, and acquisitions
Ability to broadly represent department functions on project teams in a matrix organization
Proficient with electronic systems
Prior management experience preferred
Position may require up to 5% travel

Benefits

Comp & perks

Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance
Flexible Time Off (FTO) for U.S.-based exempt employees
11 paid company holidays each year
160 hours of paid vacation annually for eligible new hires
3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
Paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs, depending on eligibility
Annual Global Shutdown between Christmas Day and New Year's Day
Additional discretionary incentive cash and stock opportunities
Workplace accommodations/adjustments and ongoing support for people with disabilities