Manager II, Regulatory Portfolio Management

Bristol Myers Squibb; Warszawa; On-site; PLN 179,000 - 217,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland, seeks a Regulatory Portfolio Manager to coordinate cross-functional regulatory activities and ensure timely, compliant portfolio deliverables. The role emphasizes collaboration with GRST teams, adherence to global processes, and alignment with local regulatory requirements.

The position involves leading regulatory strategy execution, intelligence, and submissions support, with opportunities to impact product lifecycle decisions and strategic partnerships

Qualifications

• Minimum of a Bachelor degree in 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 and set a good example
• Identify, resolve and manage completion of issues and communicate implications to the project team
• Excellent communication and organizational skills and meticulous attention to detail
• Facilitate negotiation with Health Authorities and key partners on routine matters with supervisory consultation
• Ability to make decisions in their sphere of influence
• Independently work on multiple projects and assignments
• Ability to lead cross-functional teams under supervision

Responsibilities

• Coordinate and support cross-functional regulatory teams to ensure deliverables
• Support execution of regulatory strategy and communicate milestones
• Participate in regulatory intelligence and policy discussions
• Support global regulatory submissions and information management
• Assist in divestitures, product deletions, and asset integration activities
• Coordinate HA responses and schedule reviews
• Drive operational excellence and process improvements
• Contribute to analytics and compliance reporting

Skills

Regulatory experience

Communication skills

Organizational skills

Stakeholder management

Decision making

Cross-functional collaboration

Education

Bachelor's degree in Natural Science or Pharmacy

Tools

Verity

Infinity

Job description

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 Regulatoryto ensure regulatory portfolio deliverables are delivered to plan and in compliance with global processes andappropriate localregulatory requirements.

Position Responsibilities

Responsibilitiesincludebut not limited to:

Global Regulatory Support

• Facilitate and mayCo-lead GRST meetings in alignment with the GRS Culture Playbook to ensurehigh qualitydiscussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making

Execution of Regulatory Strategy

• Develop andmaintainasset global regulatoryBoW

• Liaise cross-functionally tocommunicate keymilestonefortimelysynchorizationin reporting

• Communicatestatus and timeline changesacross activities

• Tracking key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc.

Regulatory Intelligenceand Policy

• Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) anddetermineimpacton global regulatory strategy

• Performs complex analyses, as directed

• Monitors key Health Authority Websites for pertinent information

• Compiles Regulatory precedents as requestedin collaboration with Portfolio Acceleration & Analytics team to share at GRTto assess health authority trend analyses

GlobalRegulatory Submissions Support

• Support submission teamBOWmeetingse.g.datapreparationto enhance GRT discussions

• Maintanenaceof Regulatory Information Management records,e.g.HA Commitments

Support of Divestitures / Product Deletions / Product Termination / Asset Integration

• Product Divestiture:

• Works with the Divestiture RegLeadto document any gaps to bedisclosedto the buyer

• Works with Divestiture Reg Lead on implementation of MAT transfers, provides status updates

• Coordinates reviewof Asset Purchase Agreement, Transitional Service Agreement

• Asset / Company Integration:

• Gathersinformation 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 toidentify,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,egsubmission, Approvals, key achievements, miles stones

• ReviewVerity and Infinity reports for Compliance related trends,egHA commitments, Development commitments,openCAPAs, CAPAs coming due

Requirements

• Minimum of aBachelordegree ina NaturalScience, Pharmacy, or other Healthcare-related field

• ≥3years in pharmaceutical industryand regulatory experience

• Solidunderstanding of at least one major Health Authority (FDA, EMA, MHRA…..) regulations and Regulatory standards

• Act as a role model & set a good example

• Identify,resolveand manage completion of issues.Articulate the implication ofissueto and across projectteamon risk/benefit strategiccomponent.

• Excellentcommunication and organizational skills and a meticulous eye for details

• Facilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation.

• Ability tomake decisionsin 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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. 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 [e-mail] 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