Director, Regulatory CMC - Cell Therapy

Bristol Myers Squibb • San Diego, CA

9d • $199,950 - $271,405

About The Position

The Director, Regulatory CMC (GRS-CMC) oversees multiple development and life-cycle management projects of varying priorities and complexities. The role represents GRS-CMC on cross-functional teams, governance committees, and due diligence or in-licensing projects, and represents Bristol Myers Squibb at Health Authority meetings. The Director serves as a credible spokesperson with stakeholders and Health Authorities, develops strategic direction informed by global regulatory guidelines and experience, and seeks opportunities for external regulatory engagement for themselves and team members.

The position develops and communicates regulatory strategy; prepares or oversees CMC submissions and reviews submissions for strategic and technical clarity; uses electronic systems for dossier creation, review, tracking, and regulatory information management; and supports regulatory policies and procedures. It also includes people leadership, participation in leadership and department meetings, anticipating regulatory paradigm shifts, and representing GRS-CMC in product fact-finding meetings and R&D forums. The role maintains oversight of regulatory compliance, including timely and accurate data entry in the Regulatory Information Management system.

The role requires a minimum bachelor's degree and at least 10 years of pharmaceutical or related experience, including 8 or more years in regulatory CMC. Relevant expertise includes CMC regulatory requirements for advanced therapies and/or cell therapy, pharmaceutical development, global regulatory strategy, Health Authority interactions, and cross-functional leadership. Travel of up to 5% may be required. Compensation varies by listed U.S. location, with starting ranges from $199,950 to $271,405. The position is described as full-time.

Requirements

• Minimum BA/BS degree.
• Minimum 10 years of pharmaceutical or related experience and 8 or more years of regulatory CMC experience.
• Knowledge of CMC regulatory requirements for advanced therapies and/or cell therapy during development and, as applicable, post-approval.
• Knowledge of pharmaceutical development, including advanced therapies and/or biologic or cell therapy upstream and downstream processes, analytical methods, and cell therapy products, as applicable.
• Ability to develop and maintain strong working relationships, participate in and/or lead multifunctional teams, prioritize multiple projects, and work independently.
• Ability to interact with CMC technical experts on technical issues, including process development and analytical matters.
• Understanding of scientific content and complexities and drug development, with demonstrated success delivering effective global regulatory strategies coordinated with clinical plans and marketing objectives leading to successful registration.
• Experience leading cross-functional teams, driving quality decision-making, and organizing and prioritizing tasks.
• Ability to negotiate with and influence others and facilitate issue resolution and conflict management.
• Direct experience developing strategy and leading teams through Health Authority interactions, with a track record of resolving issues with main regulatory authorities and explaining complex scientific content in logical components.
• Strong understanding of global agency policy, laws, regulations, and guidelines as they apply to drug development and approval.
• Good interpersonal skills, willingness to leverage team strengths and cooperate with peers, and an orientation toward continuous improvement.
• Experience communicating regulatory strategy, issues, and risks in written and verbal formats to regulatory senior leadership and other governing bodies.
• Clear, transparent, and honest communication; setting high expectations; accountability for decisions and results; and ownership beyond the immediate area of responsibility.
• Experience as a member of a CMC Team, GRTs, project working groups, or comparable experience.
• Ability to broadly represent department functions on project teams in a matrix organization.
• Ability to consider multiple perspectives and listen openly to others.
• Proficiency with electronic systems.

Nice To Haves

• Multidiscipline pharmaceutical or related experience is preferred.
• Experience developing product partnership strategy, including out-licensing, divestiture, co-development, in-licensing, and acquisitions.
• Prior management experience.

Responsibilities

• Oversee management of multiple development and life-cycle management projects with varying priorities and complexities.
• Represent GRS-CMC on cross-functional teams, governance committees, and due diligence or in-licensing projects.
• Represent Bristol Myers Squibb at Health Authority meetings and serve as a spokesperson in discussions with stakeholders and Health Authorities.
• Develop and communicate strategic direction based on global regulatory guidelines and experience.
• Prepare or oversee preparation of CMC submissions, ensuring thoroughness, completeness, and timeliness.
• Review CMC Lead submissions for clarity of strategic and technical content.
• Use 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 as a GRS-CMC representative.
• Support preparation of CMC policies and procedures.
• Maintain regulatory compliance oversight and promote timely, accurate data entry in the Regulatory Information Management system.
• Seek opportunities for external regulatory engagement for themselves and/or team members.

Benefits

• Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
• Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• Paid company holidays: 11 annually for eligible employees.
• For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval, and 3 optional holidays.
• Depending on eligibility, 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.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Additional discretionary incentive cash and stock opportunities may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Director