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

Bristol Myers Squibb; München; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager Regulatory Sciences Innovative Medicines in Germany. You will oversee local regulatory activities from development to lifecycle management, coordinating with BfArM/PEI and internal stakeholders to ensure compliant regulatory submissions and strategy alignment.

Join a purpose-driven, cross-functional team and shape regulatory pathways for innovative medicines, contributing to patient outcomes and lifecycle management across the German market.

Qualifications

• At least 4 years experience in Regulatory Sciences or related areas in a pharmaceutical company.
• 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.
• Broad understanding of the drug development process (clinical, pre-clinical, pharmaceutical).
• Knowledge of European Regulatory requirements for clinical trial applications.
• Knowledge of industry and external health environment at local and European level.
• Scientific background in Medical/Pharmaceutical/Natural Sciences.

Responsibilities

• Proactive communication and explanation of European regulatory strategies to cross-functional teams.
• Report changes/trends in regulatory procedures impacting HTA strategy and country needs.
• Engage with BfArM/PEI and other authorities as primary country regulatory contact.
• Contribute to AMNOG dossier work and cross-functional Country Brand Teams.
• Align CTIS submissions with clinical trial applications and local HA communication.
• Ensure compliant launches and updates to Marketing Authorisations (SmPCs and PILs).
• Collaborate with Pharmacovigilance and Medical on DHCP letters and RMP materials.

Skills

German language

English language

Crossfunctional teamwork

Strategic communication

Education

Medical/Pharmaceutical/Natural Sciences degree

Job description

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

How We WorkWhere 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 DisabilitiesBMS 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 applic