Director, US Regulatory Lead

Role Overview

• 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.

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.

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.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays).
• Based on eligibility*, additional time off for employees may include 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.