Manager II, Regulatory Portfolio Management

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The role is to provide coordination and operational support to cross-functional regulatory teams and Country Regulatory   to ensure regulatory portfolio deliverables are delivered to plan and in compliance with global processes and   appropriate local   regulatory requirements .

Responsibilities Responsibilities   include   but not limited to :   Global Regulatory Support   Facilitate and may   Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure   high quality   discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making   Execution of Regulatory Strategy   Develop and   maintain   asset global regulatory   BoW Liaise cross-functionally to   communicate key   milestone   for   timely   synchorization   in reporting  Communicate   status and timeline changes   across activities   Tracking key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc.   Regulatory Intelligence   and Policy   Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and   determine   impact on global regulatory strategy   Performs complex analyses, as directed   Monitors key Health Authority Websites for pertinent information    Compiles Regulatory precedents as requested   in collaboration with Portfolio Acceleration & Analytics team to share at GRT   to assess health authority trend analyses   Global   Regulatory Submissions Support   Support submission team   BOW   meetings   e.g.   data   prepa ra tion   to enhance GRT discussions          Maintanenace   of Regulatory Information Management records,   e.g.   HA Commitments     Support of Divestitures / Product Deletions / Product Termination / Asset Integration   Product Divestiture:    Works with the Divestiture Reg   Lead   to document any gaps to be   disclosed   to the buyer   Works with Divestiture Reg Lead on implementation of MAT transfers, provides status updates   Coordinates review   of Asset Purchase Agreement, Transitional Service Agreement   Asset / Company Integration:   Gathers   information to support Sponsorship Change Strategy   Support Integration Lead in meetings with cross-functional team   HA queries / Shortage Notifications   Coordination of HA responses (work with respective GRL, RPM, CMC-L, International Lead, EU Lead)    Schedule RRT meetings and communicate timelines   Review HAQ in Verity to   identify ,   whether similar query was previously received   Follow-up with SME in response sections   Operational Excellence   Looks for opportunities for continuous improvement in processes and technology solutions,   e.g.   contribute to initiative working group(s)  Analytics / Compliance Activities   Support preparation of GRS analytics and monthly dashboards,   eg   submission, Approvals, key achievements, miles stones   Review   Verity and Infinity reports for Compliance related trends,   eg   HA commitments, Development commitments,   openCAPAs , CAPAs coming due   Requirements Minimum of a   Bachelor   degree in   a Natural   Science, Pharmacy, or other Healthcare-related field   ≥  3   years in pharmaceutical industry   and regulatory experience   Solid   understanding of at least one major Health