Senior Manager, Regulatory Sciences (m/w/d)

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.

Position Summary

The Senior Manager Regulatory Sciences Innovative Medicines is accountable for the local regulatory oversight of the assigned BMS products in Germany, from clinical development through the marketed lifecycle, ensuring compliance with Marketing Authorisations and national requirements. Acts as the primary regulatory point of contact at country level for German health authorities BfArM/PEI as well as internal stakeholders (e.g. Country Brand Teams, European Regulatory Teams, Medical, Pharmacovigilance), ensuring clear communication, effective coordination and consistent alignment between European strategy and local needs.

Duties/Responsibilities

Strategy:

Proactive communication and explanation of European regulatory strategies in the Country Cross Functional Teams

Immediate communication of changes/trends in regulatory procedures that could, for example, have an impact on HTA strategy

Proactive communication of market-specific conditions and needs with regard to European regulatory strategies to European and Global Regulatory Teams

Support pipeline strategy discussions

Health Authority contact:

Contact person for and close cooperation with the German regulatory authorities (BfArM and PEI) and competent supervisory authorities (e.g. Government of Upper Bavaria) in the area of responsibility

Crossfunctional Collaboration and Support:

Active member of respective AMNOG dossier team and support of JCA process

Active member of respective cross-functional Country Brand Teams

GMO in Clinical Trials:

GMO submission aligned with clinical trial applications in CTIS, including respective local HA communication, if applicable

Close cooperation with the Department of Regional Clinical Operations at German and international level, exchange of knowledge and communication of national requirements

Compliance:

Ensure compliant implementation of launches and ongoing updates to the Marketing Authorisations (by updating of SmPCs/PILs and relevant regulatory documents)

Good knowledge of the pivotal studies, which were the basis for respective approvals and main contact person for in- and off-label questions

Ensure that promotional materials comply with in-label content of SmPC and Packaging Leaflet information, as a substitute for the person responsible for scientific services according to Art. 98, Directive 2001/83/EC for centrally authorized products

Close cooperation with the Pharmacovigilance and the Medical Department in the preparation of DHCP letters and RMP materials

Experience Requirements

At least 4 years experience in Regulatory Sciences or related areas in a pharmaceutical company (e.g. Medical, Safety, Clinical Research)

Proficiency in German and European Regulatory requirements and procedures

Good knowledge of the AMNOG process

Experience in regulatory support to clinical development strategy

Experience in directly interacting with Health Authorities

Good understanding of the entire drug development process, including clinical, pre-clinical and pharmaceutical development

Good knowledge of European Regulatory requirements for clinical trial applications

Knowledge of industry and external health environment at local and European level

Scientific background (degree in Medical/ Pharmaceutical/ Natural Sciences)

Key Competencies Required

Ability to work in a diverse and complex international organization

Strong crossfunctional Teamwork competency

Good verbal and written communication skills (both in English and German)

#LI-Hybrid

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.

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 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  adastaffingsupport@bms.com . Visit  careers.bms.com/eeo-accessibility  to access our complete Equal Employment Opportunity statement.

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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/

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R1607665 : Senior Manager, Regulatory Sciences (m/w/d)