Manager, Regulatory Portfolio Management

Job description

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 Natural Science, Pharmacy, or other Healthcare-related field ≥ 3 years in pharmaceutical industry and regulatory experience Solid understanding of at least one major Health Authority (FDA, EMA, MHRA …..) regulations and Regulatory standards Act as a role model & set a good example Identify, resolve and manage completion of issues. Articulate the implication of issue to and across project team on risk/benefit strategic component. Excellent communication and organizational skills and a meticulous eye for details Facilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation. Ability to make decisions in their sphere of influence Independently work on multiple projects & assignments. Ability to lead cross-functional teams under supervision If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Warsaw - PL: zł179,300 - zł217,268 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial informatio