Director, US Regulatory Lead, GRS

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. 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.

Position Summary

The Director, U.S. Regulatory Lead (USRL) will oversee regulatory strategy and execution for Immunology and Cardiovascular therapeutic area, with a primary focus on management of pulmonology asset and associated Health Authority (HA) interactions along including upcoming NDA submission. The incumbent may also serve as Global Regulatory Lead (GRL)/USRL for an early or late development asset, responsible for leading IND preparation and submission, and for developing regulatory strategy across lifecycle phases.

Expected Areas of Competence

• Develop and lead U.S. regulatory strategy and execution for a Development Team (s), including first NDA submission and ensuring compliance with FDA commitments and timelines.
• Manage and lead all HA interactions including pre-NDA meeting, preparation of briefing packages, response documents, and correspondence with FDA.
• Develop US registration strategy for a product and translate that into operational deliverables for execution by external and specific internal resources, while partnering with GRL and cross-functional teams.
• Provide strategic regulatory input on the target product profile, CCDS and USPI.
• Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies.
• May Serve as Global Regulatory Lead (GRL and)/U.S. Regulatory Lead (USRL) for an early-stage or late development asset; lead preparation and filing of Investigational New Drug (IND) application and development of regulatory strategy for lifecycle phases.
• 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 regulatory experts together as needed.
• Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders.
• 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
• Ensure documents and regulatory dossiers are compiled according to appropriate standards 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.
• 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), with at least 3 years in U.S. and preferably in pulmonology and immunology area
• Proven success in delivering effective US 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
• Proven success in negotiating regulatory objectives with HA

Qualifications

• Proven success in delivering effective US 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
• Proven success in negotiating regulatory objectives with HA
• Proven success in leading cross functional matrix teams
• Proven success in breaking down complex, scientific issue and communicating regulatory implications
• Proven success in providing 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

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Paid Time Off: US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.