Director, Regulatory CMC - Cell Therapy

Bristol Myers Squibb; Lawrence Township (NJ); In loco; USD 200.000 - 242.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible Time Off

Comprehensive benefits

Holidays & shutdown

Descrizione del lavoro

Bristol Myers Squibb is seeking a Director, Regulatory CMC - Cell Therapy to oversee multiple development and lifecycle management projects. You will represent GRS-CMC on cross-functional teams and health authority discussions, shaping regulatory strategy for cell therapy programs.

The role requires deep CMC regulatory expertise, leadership and a track record in global regulatory engagement. Travel up to 5% may be required, with comprehensive benefits and a supportive, inclusive culture.

Competenze

• BA/BS degree minimum.
• 10+ years pharmaceutical or related experience, 8+ years regulatory CMC.
• Experience with advanced therapies and cell therapy developments.

Mansioni

• Develop and communicate strategic regulatory direction for CMC.
• Prepare or oversee CMC submissions ensuring thoroughness and timeliness.
• Review CMC submissions for clarity and technical content.
• Utilize electronic systems for dossier creation, review, and tracking.
• Support growth and development of direct reports.

Conoscenze

CMC regulatory knowledge

Drug development knowledge

Cross-functional leadership

Stakeholder communication

Regulatory strategy

Formazione

BA/BS Degree

Strumenti

Regulatory Information Management (RIM) system

Descrizione del lavoro

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a 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 doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Brisbane - CA - US: $224,000 - $271,405
Devens - MA - US: $213,950 - $259,251
Princeton - NJ - US: $199,950 - $242,297
San Diego - CA - US: $215,940 - $261,672
Seattle - WA - US: $219,950 - $266,523

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 Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How 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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1602987 : Director, Regulatory CMC - Cell Therapy