Director, Regulatory CMC - Cell Therapy

Bristol Myers Squibb • San Diego, NJ

1d

About The Position

The GRS-CMC Director oversees multiple development and lifecycle management projects of varying priorities and complexity. The role represents GRS-CMC on cross-functional teams, governance committees, and due diligence and in-licensing projects, and represents Bristol Myers Squibb at Health Authority meetings. The Director serves as a credible spokesperson with key stakeholders and Health Authorities and develops and communicates strategic direction based on global regulatory guidelines and experience. The role also seeks opportunities for external regulatory engagement for themselves and/or team members.

The position includes preparing and overseeing CMC submissions, reviewing submissions from CMC Leads, managing regulatory compliance and information management, and supporting the growth and development of direct reports. The Director participates in leadership and department meetings, product fact-finding meetings, and R&D forums, anticipates regulatory paradigm shifts, and supports the development of CMC policies and procedures. The role may require up to 5% travel.

Requirements

• Minimum BA/BS degree.
• Minimum 10 years of pharmaceutical or related experience.
• At least 8 years of regulatory CMC experience.
• Knowledge of CMC regulatory requirements for advanced therapies and/or cell therapy during development and post-approval, as applicable.
• Knowledge of pharmaceutical development, including advanced therapies and/or biologic and 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; manage and prioritize multiple projects; and work independently.
• Ability to interact with CMC technical experts on technical issues, including process development and analytical topics.
• Understanding of scientific content and complexities, and good knowledge of drug development, with proven success delivering effective global regulatory strategies coordinated with clinical plans and marketing objectives leading to successful registration.
• Experience leading cross-functional teams and demonstrated ability to drive quality decision-making and organize and prioritize tasks.
• Demonstrated 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, a track record of issue resolution with major regulatory authorities, and ability to break down complex scientific content into logical components.
• Strong understanding of policies, laws, regulations, and guidelines as they apply to global regulatory agencies for drug development and approval.
• Good interpersonal skills; willingness to leverage team strengths and cooperate with peers in a cross-functional environment; and orientation toward continuous improvement.
• Experience communicating regulatory strategy, issues, and risks in written and verbal formats to regulatory senior leadership and other governing bodies.
• Communicate opinions, facts, and thoughts clearly, transparently, and honestly; set high expectations; and hold self and others accountable for decisions and results.
• Demonstrate ownership of results within and beyond area of responsibility.
• 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 a project team in a matrix organization.
• Seek multiple perspectives and listen openly to others’ points of view.
• Proficiency with electronic systems.

Nice To Haves

• Multidiscipline pharmaceutical or related experience is preferred.
• Prior management experience is preferred.

Responsibilities

• 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 submissions from CMC Leads 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 actively in leadership or department meetings.
• Anticipate and communicate possible regulatory paradigm shifts.
• Participate in product fact-finding meetings and/or R&D forums representing GRS-CMC.
• Support preparation of CMC policies and procedures.
• Maintain oversight of regulatory compliance and promote high standards by monitoring and verifying timely, accurate data entry into the Regulatory Information Management system within designated timeframes.
• Represent GRS-CMC on cross-functional teams, governance committees, and due diligence/in-licensing projects.
• Represent BMS at Health Authority meetings and serve as a spokesperson in discussions with stakeholders and Health Authorities.
• Seek opportunities for external regulatory engagement for themselves and/or team members.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• For specified non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval.
• 11 paid company holidays each year; specified employee groups also receive 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.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

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