Manager II, Regulatory Portfolio Management
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moAt 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.
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
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
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.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
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 qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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 information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
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