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.

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   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 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

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:

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.

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.

R1604168 : Manager II, Regulatory Portfolio Management