Manager, Regulatory Portfolio Management

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Summary 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. Position 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 preparation 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...