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Job Details


Bristol Myers Squibb

Director, Regulatory Affairs - Immunology, Neuroscience, Fibrosis

Healthcare

Medical Director

No

Cambridge, Massachusetts, United States

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

Expected Areas of Competence
• Develop and lead Global 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 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 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 guidelines


Behaviors
• 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

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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To 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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.