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Manager II, Regulatory Portfolio Management w… - Jobeax

Manager II, Regulatory Portfolio Management w Warszawa, Polska is listed on Jobeax. Browse 110,000+ vacancies available.

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

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 & Policy
- Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impacton 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
≥3years in pharmaceutical industryand 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 ofissueto and across projectteamon risk/benefit strategiccomponent .
Excellent communication 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.

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

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 role. Applicants can request a reasonable workplaceaccommodations/adjustments prior to accepting a job offer. If you require reasonableaccommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries Wyświetl e-mail na https://jobeax.com/link/8om4ubga9gvjbUNE . https://jobeax.com/link/A9gAMdda1PD4JhmD 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.

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

R1604168 : Manager II, Regulatory Portfolio Management

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