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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. Read more: careers.bms.com/working-with-us.

Job Description:

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 of Regulatory Materials is responsible for Leading the GRS-CMC Operations Regulatory Materials group and directly supervise Senior Managers and Managers while Collaborating with stakeholders across functional area to enhance business processes and provide strategic input for the Information Technology (IT) systems and processes utilized for change control, Regulatory Information Management (RIM), and serve as Subject Matter Experts for change control system and on preparation/review and issuance of regulatory compliance statements related to materials utilized in manufacturing processes and samples.

Duties/Responsibilities:

• Responsibility is for TSE (Transmissible Spongiform Encephalopathies) Regulatory Compliance Statements, preparation & management of TSE regulatory documentation, performing TSE risk assessments, performing TSE risk assessments and administration of the Global Data Repository (GDR) computer system used to manage TSE
• Prepare statements to assess the presence of Allergens, Genetically Modified Organisms (GMO), or other material attributes (e.g. alcohol, pork, halal) in BMS products
• Coordinate Inter International Product Registration (IPR) requests for delivery of product samples, critical assay reagents and Reference Standards to countries that require in-country Quality Control testing
• Subject Matter Expert on global Transmissible Spongiform Encephalopathies (TSE) regulatory requirements
• Provide regulatory leadership to support business teams with guidance and strategic solutions on TSE matters
• Evaluate TSE documentation for compliance and prepare TSE regulatory compliance statements for BMS product. Perform TSE risk assessments
• Administer the Global Data Repository (GDR) system for management of TSE program

• Partner with IT for GDR system upgrades and train users on use of GDR at manufacturing sites. Provide GDR troubleshooting and support to manufacturing sites
• Prepare/review TSE sections of regulatory filings and respond to related Health Authority questions
• Review and provide impact assessments of manufacturing change controls as they relate to TSE
• Develop, implement and maintain systems and processes related to company TSE program
• Subject Matter Expert on Allergens. Maintain the BMS Allergen database. Prepare and issue Allergen regulatory compliance statements
• Subject Matter Expert on Genetically Modified Organisms (GMO) to meet Health Authority requirements. Prepare and issue GMO regulatory compliance statements
• Subject Matter Expert for change control system in close collaboration with QA and IT Teams related to GRS-CMC user requirements, implementation of updates and maintenance
• Prepare and issue regulatory compliance statements for other material attributes (e.g. presence of alcohol, pork, halal)
• Support International Product Registration (IPR) responsibilities, including the registrational sample process and coordination of shipment of product samples, critical reagents, and reference standards to local countries to support QC registrational testing
• Support Medical Information program relating to marketed products
• Utilize electronic systems for review and creation of TSE related documents, coordination/tracking of registrational samples and medical information
• Author and review procedural documents
• Interpret global regulations and guidance
• Communicate with project teams; with regards to technical issues that may impact regulatory materials, strategy, or success
• Anticipate and communicate possible regulatory paradigm shifts
• Manage relationships with diverse teams
• Utilize electronic systems
• 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
• 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 or Senior Director, Global Regulatory Sciences - CMC

Qualifications:

• Minimum BA/BS Degree
• 8+ years pharmaceutical industry experience – prefer knowledge of small molecules, biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory or TSE related experience, 2+ years as direct line people manager
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicable
• Strong Information Technology (IT) knowledge related to systems operation, user requirements, validation, implementation and maintenance
• Strong oral and written communication skills with the ability to effectively impact project teams with strategic solutions to issues. Participate or lead multifunctional teams related to TSE
• Proficient navigation of electronic systems, including formatting and electronic management of data and information
• Ability to interpret global TSE regulations and guidance, including proficient use of resources to stay current with emerging standards and regulations.
• Manage and prioritize multiple projects and complex assignments independently
• Establish effective working relationships with business units and key business partners to achieve assigned objectives
• 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
• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
• Must be able to innovate, analyse 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
• 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
• Analyze and measure the effectiveness of existing business processes within the GRS-CMC department and identify opportunities to improve business practices and processes to maximize resources
• Ability to identify, communicate and resolve complex issues
• 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

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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/

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