Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. 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. Position Summary / Objective Lead and or/support the creation and approval of global regulatory plans in conjunction with Regulatory Leads Position Responsibilities In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across immunology. Lead and/or support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers. Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT. Propose approaches to resolve regulatory issues and appropriately drive speed to patients. Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities. Lead the preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP, ) etc. Understanding of scientific content, drug development and regulatory requirements. Participate in the assessment of regulatory precedence and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g. registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom. Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops. Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities). Facilitate identification of and internal agreement on target labeling Degree / Experience Requirements Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience At least 2-4 years of relevant regulatory experience or 4-8 years pharmaceutical industry experience. Key Competency Requirements: A basic knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required. Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers within in a cross-functional environment. Proven ability to work with outside partners. Demonstrated ability to be solution-oriented Seeks multiple perspectives and listens openly to others’ points of views. Enables and demonstrates the courage to speak up on issues and risks as well as on the good news. 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. Other Qualifications: 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 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 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 an inclusive culture, promoting diversity 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. 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 [email protected]. 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. 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