Director, Regulatory Strategist, GRS

Expected Areas of Competence

• Develop and lead Global and US 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.
• Lead the resolution of critical regulatory project issues, bringing 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.
• Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources.
• Formulate US regulatory strategy and filings.
• Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors.
• Audit and ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines.

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.
• Demonstrated ability to break down complex, scientific issues and communicate regulatory implications.
• Proven success in negotiating regulatory objectives with HA.

Behavioral Expectations

• 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.

Education and Experience Requirements

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS.
• Significant experience in regulatory affairs (e.g. > 4-7 years).