Director, Regulatory Affairs - Immunology, Neuroscience, Fibrosis

Company: Bristol Myers Squibb
Location: Cambridge
Posted on: March 15, 2023

Job Description:

Working with UsChallenging. 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: Expected Areas of Competence--- Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.--- Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans--- Provide leadership to resolve critical regulatory project issues, bring the appropriate regualtory experts together as needed--- Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders--- Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources--- Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies--- Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters--- Provide strategic regulatory input on the target product profile, CCDS, and country-specific label--- Create an asset specific Global and US -HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions--- Formulate US regulatory strategy and filings--- Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors--- Approval of regulatory documents--- Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelinesBehaviors--- Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners.--- Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting--- Generates alternative regulatory strategies and plans, and assesses benefits and risks.--- Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources.--- Creates a unified and seamless team using both internal and external resources to execute regulatory strategy--- Communicates opinions, facts and thoughts with clarity, transparency and honesty--- 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.--- Develops and applies unique ideas and new methods to achieve higher performance and excellence.--- Works across organizational, functional and geographic boundaries to achieve company goals.--- Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.--- Demonstrates resilience and perseverance. -Degree / Experience Requirements

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
• Significant experience in regulatory affairs (e.g. > 4-7 years)Qualifications--- Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.--- Excellent in communicating regulatory strategy, issues, and risks in written and verbal format--- Experience leading cross functional matrix teams--- Demonstrated ability to break down complex, scientific issue and communicating regulatory implications--- Proven success in negotiating regulatory objectives with HA#LI-Hybrid The starting compensation for this job is a range from $173,000-$244,000, plus incentive cash and stock opportunities (based on eligibility). - The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. - Final individual compensation will be decided based on demonstrated experience. - -For more on benefits, please visit our https://careers.bms.com/working-with-us. - Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location. -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 CareersWith 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 ProtocolPhysical 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.COVID-19 InformationTo protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. -Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. -This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol Myers Squibb, Cambridge , Director, Regulatory Affairs - Immunology, Neuroscience, Fibrosis, Healthcare , Cambridge, Massachusetts