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.

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) anddetermineimpact on 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

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 .

Visit 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.

Data Protection

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1604168 : Manager, Regulatory Portfolio Management