Senior Manager, Global Regulatory Sciences EU & International

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Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Summary

Global Regulatory Sciences (GRS) partners with global and local teams to deliver regulatory strategies that enable approvals launches and lifecycle management across the this role you will shape end-to-end EU/International regulatory strategy in close partnership with global regulatory lead (GRL) and Country Regulatory Manager (CRM) from early development through post-approvaltranslating evolving Health Authority expectations into clear executable plans for the program. You will lead cross-functional alignment and Health Authority engagement (e.g. EMA) ensuring consistent positions high-quality submissions and timely responses to regulatory agency questions. By combining regulatory intelligence with strong stakeholder partnership you will optimize registration pathways anticipate risk and maintain compliance to maximize product value and patient access. This is a visible role where your leadership cross-functional collaboration and regulatory guidance directly influence successful delivery of the portfolio in the EU and International region.

Key Responsibilities

• Coordinate the development of European and International submission plans post-approval lifecycle management plans (e.g. variations renewals) and Health Authority interaction plans in alignment with global development and lifecycle strategies partnering closely with the GRT and Country Regulatory Managers (CRMs).
• Define and lead European submission plan and support CRMs for defining the International submission strategies and Health Authority engagement plans ensuring alignment with global objectives and regional needs.

• Provide timely project updates to European and International countries to support execution of agreed registration strategies and ensure launch readiness.
• Contribute to defining EU/International registration scenarios procedural timelines and risk assessments supporting alignment with the Global Regulatory Lead (GRL) and commercial partners.
• Maintain robust submission and procedural strategies covering country-specific requirements bridging strategies ethnic sensitivity and sourcing under established strategic frameworks.
• Support preparation for and participate in key health authority interactions; contribute to consistent regulatory positions and draft responses to HA queries for assigned regions/countries.
• Contribute to the development of target labelling and labelling updates in alignment with global reference documents.
• Provide regulatory input to key development and lifecycle management documents (e.g. clinical trial application (CTA) variations renewals paediatric and orphan applications protocols) ensuring content is regionally compliant and aligned with the overall regulatory strategy.
• Support or lead (as delegated) cross-functional rapid response activities to address EU CTA queries and protocol amendments within health authorities timelines helping ensure timely compliant responses.
• Facilitate and participate in cross-functional meetings; act as a regulatory subject matter contributor for European and International topics.
• Support preparation of documentation for EMA and EU national authority interactions including scientific advice and pre-submission activities.
• Support Country Regulatory Managers in responding to health authority queries and preparing high-quality submissions and documentation.
• Monitor regulatory guidelines and evolving requirements escalating relevant intelligence and risks.
• Participate in peer reviews internal initiatives and regulatory forums; support maintenance of company core data sheet (CCDS)/reference label alignment and key regulatory compliance deliverables in coordination with global and local stakeholders.
• May support Global Regulatory Lead or other regulatory regional leads as required.

Qualifications & Experience

Scope & Contribution

• Solid understanding of pharmaceutical product development and EU/International regulatory principles with the ability to apply this knowledge to defined programs or products under guidance.
• Working knowledge of global regulatory requirements for drugs in development and the tactical role of GRS across development and lifecycle activities.

Execution & Problem Solving

• Demonstrated ability to break down complex scientific and regulatory content into logical components to support submissions responses and internal decisionmaking.
• Proven ability to organize and prioritize tasks effectively facilitating issue resolution within established regulatory strategies and timelines.
• Ability to react appropriately in challenging or timecritical situations escalating risks and proposing solutions as needed.

Collaboration & Credibility

• Experience contributing to scientific and regulatory documents and participating in interactions with regulatory authorities building credibility with internal and external stakeholders.
• Demonstrated effectiveness working in crossfunctional teams and supporting collaborative regulatory execution across regions.

At least 5 years of relevant regulatory experience in EU and/or International and/or Global regulatory position

If you come across a role that intrigues you but doesnt 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.

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 employees 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.

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