Director, US Regulatory Lead, GRS

Director, US Regulatory Lead, GRS

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.

• 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 U.S. 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) / 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.

• 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.

• 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 U.S. 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…