Challenging. Meaningful. Life-changing. Those aren’twords that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquelyinteresting work happens every day, in every department. Fromoptimizing a production line to the latest breakthroughs in celltherapy, this is work that transforms the lives of patients, andthe careers of those who do it. You’ll get the chance to grow andthrive through opportunities uncommon in scale and scope, alongsidehigh-achieving teams rich in diversity. Take your career fartherthan you thought possible. Position Responsibilities - Leadershipresponsibility for global regulatory strategy within a developmentteam (DT). - Serve as team lead or co-lead of marketing applicationsubmission teams for indications that are at the regulatory filingstage; helping to develop strategy and content for global dossiers. - Support the preparation of, and participate in / lead (asappropriate), key HA interactions. Assure consistent positions oncommon issues are presented to global HA. Review and approvecontent of responses to queries from HAs for respective regions /countries. - Prepare content for regulatory strategic documentationand Regulatory Project Reviews. Align regulatory plans withcommercial and development plans. - Develop target labeling andco-lead the cross-functional labeling team. - Ensure consistentpositions are presented in responses to global health authority(HA) queries. - Ensure global development plans will meet globalregulatory requirements by soliciting and integrating regionalregulatory strategy liaison input. - In collaboration with theglobal regulatory team (GRT), develop global submission plans and Health Authority interaction plans. - Provide strategic regulatoryinput to key development documents, including clinical protocols,clinical and nonclinical reports and summary documents, statisticalanalysis plans, DMC charters, IBs, DSURs, etc. - Co-lead thecross-functional rapid response teams to respond to Clinical TrialApplication (CTA) queries on new protocols and protocol amendmentsin compliance with HA deadlines. Degree Requirements Solidscientific background, Ph. D., M.D., PharmD, MS, or BS. ExperienceRequirements Significant experience in regulatory affairs (e.g.> 4-7 years). Key Competency Requirements Required : -Understanding of scientific content and complexities and goodknowledge of Oncology drug development is desired. - Understandingof strategic and tactical role and deliverables of GlobalRegulatory Strategy in the Product Development and Commercialization process. - Understanding of policy, laws,regulations and guidelines as they apply to Regulatory Agenciesglobally for drug development and approval. - Good interpersonalskills; willingness to leverage strengths of the team and cooperatewith peers in a cross-functional environment. - Experience insuccessfully leading teams; Demonstrated ability to drive qualitydecision-making. Demonstrated ability to organize / prioritizetasks. - Demonstrated ability to negotiate with and influenceothers. Demonstrated ability to facilitate issue resolution andconflict management. Direct experience in developing strategy andleading teams through interactions with health authorities. - Trackrecords of issue resolutions with main regulatory authorities;demonstrated ability to break down complex, scientific content intological components. - Experience with developing and documentingregulatory strategies in coordination with clinical plans andmarketing objectives. - Experience with communicating theregulatory strategy, issues, and risks in written and verbal formatto regulatory senior leadership team and other governing bodies. -Ability to broadly represent department functions on project teamin a matrix organization. Demonstrated ability to coordinate globalactivities. - Experience as a member of GRTs, project workinggroups, or comparable experience. Experience developing strategyfor product partnership (out-licensing, divestiture,co-development, in-licensing, and acquisitions). - Experienceutilizing leadership techniques to drive a team through the stagesof team development. Other Qualifications : - Strong team player,using both internal and external resources to execute regulatoryactivities and working across organizational, functional andgeographic boundaries to achieve company goals. - Communicatesopinions, facts and thoughts with clarity, transparency andhonesty. - Demonstrates ownership of results within (and beyond)area of responsibility. - Sets clear and high expectations andholds self and others accountable for decisions and resultsachieved. - Looks for opportunities for continuous improvement. Uniquely Interesting Work, Life-changing Careers With a singlevision as inspiring as “Transforming patients’ lives throughscience,” every BMS employee plays an integral role in work thatgoes far beyond ordinary. Each of us is empowered to apply ourindividual talents and unique perspectives in an inclusive culture,promoting diversity in clinical trials, while our shared values ofpassion, innovation, urgency, accountability, inclusion andintegrity bring out the highest potential of each of ourcolleagues. On-site Protocol BMS has a diverse occupancy structurethat determines where an employee is required to conduct theirwork. This structure includes site-essential, site-by-design,field-based and remote-by-design jobs. The occupancy type that youare assigned is determined by the nature and responsibilities ofyour role: Site-essential roles require 100% of shifts onsite atyour assigned facility. Site-by-design roles may be eligible for ahybrid work model with at least 50% onsite at your assignedfacility. For these roles, onsite presence is considered anessential job function and is critical to collaboration,innovation, productivity, and a positive Company culture. Forfield-based and remote-by-design roles, the ability to physicallytravel to visit customers, patients or business partners and toattend meetings on behalf of BMS as directed is an essential jobfunction. BMS is dedicated to ensuring that people withdisabilities can excel through a transparent recruitment process,reasonable workplace accommodations / adjustments and ongoingsupport in their roles. Applicants can request a reasonableworkplace accommodation / adjustment prior to accepting a joboffer. If you require reasonable accommodations / adjustments incompleting this application, or in any part of the recruitmentprocess, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about yourwell-being and the well-being of our staff, customers, patients,and communities. As a result, the Company strongly recommends thatall employees be fully vaccinated for Covid-19 and keep up to datewith Covid-19 boosters. BMS will consider for employment qualifiedapplicants with arrest and conviction records, pursuant toapplicable laws in your area. Any data processed in connection withrole applications will be treated in accordance with applicabledata privacy policies and regulations. #J-18808-Ljbffr Physicians