Bristol Myers Squibb Director, Global Regulatory Strategist in Princeton, New Jersey
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
• 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.
• 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
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.