Job Title

About Bristol Myers Squibb: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.Director / Global Regulatory Sciences - CMCPosition 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 siteMay have an assigned book of work to directly work onActively participates in leadership or department meetingsAnticipate and communicate possible regulatory paradigm shiftsParticipate in product fact finding meetings and/or R&D forums representing GRS-CMCManage relationships with diverse teamsSupport the preparation of CMC policies and proceduresEnsure 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 timeframesLooks for opportunities for continuous improvement in processes and technology solutionsParticipate 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 positionsBuild and lead a diverse, high-performing Team through targeted recruitment, engagement, coaching and mentoring; build succession plans for key positionsProvide strategic leadership and set direction and priorities aligned to the company’s strategyProactively and fluidly manage the Team to take advantage of unplanned opportunities and overcome unforeseen obstacles with a focus on continuous improvement via processes and technologyActively participate in GRS and BMS people manager forumsMaintain 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 timeframesEnsure Team completes training assignments within designated timeframesQualifications:Minimum B Pharma DegreeMinimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experienceKey Competencies:Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicableKnowledge 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 applicableAbility to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independentlyAbility to interact with CMC technical experts regarding technical issues such as those related to process development and analyticalUnderstanding 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 registrationExperience leading cross-functional teams, demonstrated ability to drive quality decision-making and ability to organize / prioritize tasksDemonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict managementDirect 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 componentsStrong understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approvalGood interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment; looks for opportunities for continuous improvementExperience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodiesCommunicates 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 responsibilityExperience 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 organizationSeeks multiple perspectives and listens openly to others’ points of viewsPrior management experience preferredProficient with electronic systemsThis position may require up to 5% of travel