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.
Position Summary
- The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.
- The GRS-CMC Associate Director will lead a team of CMC regulatory professionals, setting priorities and overseeing the quality and timeliness of the team’s CMC submissions across multiple development and life-cycle management projects of varying priorities and complexities.
- The Associate Director supports the growth and development of team members, represents GRS-CMC on cross-functional teams, serves as a credible, respected spokesperson in discussions with key stakeholders, and seeks opportunities for external regulatory engagement for themselves and members of their team.
- The GRS-CMC Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support BMS products regarding: Clinical trial applications; New marketing applications; HA responses and background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director will serve as the primary interface between Global Regulatory Sciences (GRS) and Cell Therapy Development Operations (CTDO). The GRS-CMC Associate Director will assess manufacturing change controls for global impact and guide technical teams on practical aspects of global change management.
Duties/Responsibilities
- Provide direction and set priorities for the Team, aligned to GRS-CMC and company strategy, and communicate strategic direction based on global regulatory guidelines and experience
- Build and lead a diverse, high-performing Team through targeted recruitment, engagement, coaching, and mentoring
- Manage and actively support the growth and development of direct reports and/or Team members
- Proactively manage the Team to take advantage of unplanned opportunities and overcome unforeseen obstacles, with a focus on continuous improvement of processes and technology
- Oversee the preparation of CMC submissions across the Team’s projects and review submissions prepared by Team members for clarity of both strategic and technical content, thoroughness, completeness, and timeliness
- Represent GRS-CMC on cross-functional teams and, as delegated, on governance committees; serve as a credible, respected spokesperson in discussions with key stakeholders
- Act as SME on assigned or agreed regulatory policy topics related to GRS priorities and, as agreed with management, engage externally to advance key regulatory positions; seek opportunities for external regulatory engagement for self and Team members
- Actively participate in leadership or department meetings and, where the role has direct reports, in GRS and BMS people manager forums
· Ensure the Team completes training assignments within designated timeframes
· Represent regulatory CMC on and/or lead matrix teams for biologics, combination and device, cell therapy products development and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research
· Independently provide strategic guidance/input related to current regulatory requirements and expectation for marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
· Independently manage and prioritize multiple complex projects
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics
· Identify, communicate and propose resolutions to routine/complex issues
- Interpret global regulations and guidance. Identify regulatory opportunities and risks
- Provide strategic CMC regulatory expertise for development project teams
- Provide strategic input to development & GO teams to mitigate drug supply issues
- Interpret global regulations and guidance
- Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success
- Provide technical teams insight into regulatory health authority expectations
- Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success
- Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)
- Anticipate and communicate possible regulatory paradigm shifts
- Participate in product fact finding meetings and/or R&D forums representing GRS-CMC
· Review and provide regulatory assessments on change controls
· Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
· Manage relationships with diverse teams
- Utilize electronic systems for dossier creation and tracking
- 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, including data entered by Team members
- Looks for opportunities for continuous improvement in processes and technology solutions
- Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impact on global regulatory strategy
Reporting Relationship
- Director, Global Regulatory Sciences - CMC Hyderabad
Qualifications
- Minimum BA/BS Degree
- 8+ years Pharmaceutical industry experience – prefer knowledge of biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy
- Prior people management or team leadership experience preferred; experience coaching, mentoring, and developing team members
- Knowledge of CMC regulatory requirements for advanced therapies, biologics, and cell therapy during development and post-approval as applicable
- Knowledge of pharmaceutical development, including advanced therapies, biologic, and cell therapy upstream and downstream processes, analytical methods, and biologic/device combination, cell therapy products as applicable
- Expertise in the biological and cell therapy modalities, drug development process and analytical methods, preferred as applicable
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes
- Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
- Experience communicating regulatory strategy, issues, and risks, in written and verbal format, to regulatory senior leadership and other governing bodies
- Experience supporting health authority interactions on CMC topics and resolving CMC issues with regulatory authorities; ability to break down complex scientific content into logical components
- Seeks multiple perspectives and listens openly to others’ points of view
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to details
- Demonstrates ownership of results within (and beyond) area of responsibility
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved
- Looks for opportunities for continuous improvement
- Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals
- Communicates opinions, facts and thoughts with clarity, transparency, and honesty
- Experience applying project management techniques within teams. Experience in effectively managing meetings
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
- Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate
- Demonstrated ability to coordinate global activities
- Ability to identify, communicate and resolve complex issues
- Prepare and manage filings and ensure thoroughness, accuracy and timeliness
- Ability to interpret global regulations and guidance
- Strong oral and written skills
- 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.
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 adastaffingsupport@bms.com. 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, pursuant to applicable laws in your area.
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R1607716 : Associate Director -GRS CMC cell therapy