Director, Regulatory CMC Cell Therapy

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Functional Area Description

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners 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.

Position Summary / Objective

The CMC Regulatory Director, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions. In this role, the GRS-CMC Director, Cell Therapy will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Cell Therapy Development Operations (CTDO). The GRS-CMC Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.

Position Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for cell therapy pipeline products 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 biologics/cell therapy 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 oversite from supervisor on complex topics.
• Identify, communicate and propose resolutions to routine/complex issues
• Interpret global regulations and guidance. Identify regulatory opportunity and risks.
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings
• 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
• Mange relationships with diverse teams
• Utilize electronic systems for dossier creation and tracking.
  

Degree Requirements

Minimum BA/BS Degree

Experience Requirements

• Minimum of 10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 7+ years CMC regulatory strategy (biologics/cell therapy experience preferred).
• Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell therapy compounds preferred.
• Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, preferred.
• Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
• 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.
  

Key Competency Requirements

• Strong oral and written skills.
• Proficient with electronic systems
  

Travel Required

yes

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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