Director, Regulatory CMC Cell Therapy

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

The GRS-CMC Director is responsible for overseeing 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 respected spokesperson in discussions with key stakeholders and Health Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team.

Duties/Responsibilities:

• Develop and communicate strategic direction based on global regulatory guidelines and experience
• Prepare or oversee preparation of CMC submissions while ensuring thoroughness completeness and timeliness
• Review submissions from CMC Leads for clarity of both strategic and technical content
• Utilize electronic systems for dossier creation review and tracking
• Manage and actively support growth and development of direct reports
• Actively participates 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 the preparation of CMC policies and procedures
• Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes

Qualifications:

Qualifications

• Minimum BA/BS Degree
• Minimum 10 years pharmaceutical or related experience prefer multidiscipline and 8 years regulatory CMC experience

Key Competencies:

• Knowledge of CMC regulatory requirements for advanced therapies and/or and cell therapy during development and post-approval as applicable
• Knowledge of pharmaceutical development including advanced therapies and/ or biologic cell therapy upstream and downstream processes analytical methods and cell therapy products as applicable
• Ability to develop/maintain strong working relationships participate in and/or lead multifunctional teams handle and prioritize multiple projects and work independently
• Ability to interact with CMC technical experts regarding technical issues such as those related to process development and analytical
• Understanding of scientific content and complexities and good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration
• Experience leading cross-functional teams demonstrated ability to drive quality decision-making and ability to organize / prioritize tasks
• Demonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict management
• Direct experience in developing strategy and leading teams through interactions with health authorities track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex scientific content into logical components
• Strong understanding of policy laws regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval
• Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment; looks for opportunities for continuous improvement
• Experience with communicating the regulatory strategy issues and risks in written and verbal format to regulatory senior leadership team and other governing bodies
• Communicates opinions facts and thoughts with clarity transparency and honesty and sets clear and high expectations and holds self and others accountable for decisions and results achieved. Demonstrates ownership of results within (and beyond) area of responsibility
• Experience as a member of the CMC Team GRTs project working groups or comparable experience. Experience developing strategy for product partnership (out-licensing divestiture co-development in-licensing and acquisitions)
• Ability to broadly represent department functions on project team in a matrix organization
• Seeks multiple perspectives and listens openly to others points of views
• Prior management experience preferred
• Proficient with electronic systems
• This position may require up to 5% of travel

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

Compensation Overview:

Brisbane - CA - US: $246980 - $299287 Cambridge Crossing: $246980 - $299287 San Diego - CA - US: $215940 - $261672 Seattle - WA: $219950 - $266523

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including 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 also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to . Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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R: Director Regulatory CMC - Cell Therapy

Required Experience:

Director