Bristol-Myers Squibb Company

Director, Global Regulatory Strategist

Location
Princeton, NJ, US
Posted
May 12, 2018
Ref
R1120465
Required Education
Doctorate/PHD/MD
Position Type
Full time
Expected Areas of Competence

• Develop and lead Global 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
• Provide leadership to resolve critical regulatory project issues, bring the appropriate regualtory 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, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters
• Develop and approve the vendor contracts and relationships required to deliver regulatory documents and dossiers of high quality
• Provide strategic regulatory input on the target product profile, CCDS, and country-specific label
• Create an asset specific global HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions
• Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors.
• Approval of regulatory documents
• Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines

Behaviors

• 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.

This position is based in Lawrenceville, New Jersey.

Experiences/Qualifications

• PhD, MD, PharmD with at least 10 years of relevant regulatory experience
• 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