Director, Regulatory Strategist

Develop and lead Global and US Regulatory activities for a Development Team (s).
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.
Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources.
Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies.
Provide strategic regulatory input to key development documents and study reports.
Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally.
Formulate US regulatory strategy and filings.
Approval of regulatory documents.
Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines.

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

Demonstrates expertise in developing and leading global and US regulatory strategies, with a strong focus on effective communication and collaboration across cross-functional teams. Proven ability to navigate complex regulatory environments and deliver successful registration outcomes.

• Regulatory Affairs Experience
• Global Regulatory Strategy Development
• Cross-Functional Team Leadership
• Regulatory Document Approval
• HA Interaction Strategy

• Regulatory Strategy
• Regulatory Filings
• Risk Mitigation Strategies
• Scientific Communication
• Regulatory Dossier Compilation

• Effective Communication
• Influencing Skills
• Problem-Solving

• Ph.D.
• M.D.
• PharmD
• MS
• BS

• Regulatory Compliance
• Clinical Plans
• Marketing Objectives
• Global Health Authorities
• Development Plans