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Director / Global Regulatory Sciences - CMC

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 Director is responsible for overseeing the management of multiple development and life-cycle management projects of varying priorities and complexities; representing Regulatory-CMC on cross functional teams and governance committees; serving as a credible, respected spokesperson in discussions with key stakeholders and developing & communicating strategic direction based on global regulatory guidelines and experiences.

Duties/Responsibilities

• Manage and actively support growth and development of direct reports at the BMS Hyderabad site
• May have an assigned book of work to directly work on
• 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
• Manage relationships with diverse teams
• 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.
• And/or act as SME on assigned/agreed regulatory policy topics related to GRS priorities; engages externally as necessary to advance key regulatory positions
• Build and lead a diverse, high-performing Team through targeted recruitment, engagement, coaching and mentoring; build succession plans for key positions
• Provide strategic leadership and set direction and priorities aligned to the company’s strategy
• Proactively and fluidly manage the Team to take advantage of unplanned opportunities and overcome unforeseen obstacles with a focus on continuous improvement via processes and technology
• Actively participate in GRS and BMS people manager forums
• 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
• Ensure Team completes training assignments within designated timeframes

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 small molecules, biologics, and cell therapy during development and post-approval as applicable
• Knowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, 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

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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