Director, US Regulatory Lead, GRS

Bristol Myers Squibb • Needham, MA

5d • Hybrid

About The Position

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.

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
• 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

Responsibilities

• 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.

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree