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.

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   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

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 [email protected] . 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 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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604168 : Manager, Regulatory Portfolio Management