Director, Global Regulatory Lead - Brisbane CA

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, unless specifically stated otherwise, this role is 'On-Site' at the location detailed in the job post. The intended location for the role is Princeton, New Jersey and hybrid onsite requirements. 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 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, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters Provide strategic regulatory input on the target product profile, CCDS, and country-specific label Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisins to execute interactions 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 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. Minimum Education Required High School/GED Additional Qualifications/Responsibilities Solid scientific background, Ph.D., M.D., PharmD, MS, or BS Significant experience in regulatory affairs (e.g. > 4-7 years) 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 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 Compensation Overview Cambridge Crossing: $240,940 - $291,964 Madison - Giralda - NJ - US: $215,130 - $260,683 City* Brisbane State* California Job_Category Manufacturing Job Code Pharmaceutical Pharmaceutical Affiliate Sponsor Bristol Myers Sqibb BMS #J-18808-Ljbffr VetJobs