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

Bristol-Myers Squibb Co; München; Hybrid; EUR 110.000 - 190.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb Co in Germany seeks a Senior Manager Regulatory Sciences to oversee local regulatory affairs from development to lifecycle management. You will coordinate with BfArM/PEI and cross-functional teams to ensure compliant launches and ongoing regulatory updates.

The role requires strong German regulatory expertise, experience with AMNOG processes, and collaboration with medical, safety, and clinical development stakeholders.

Qualifikationen

• 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.
• Good understanding of the entire drug development process, including clinical, pre-clinical and pharmaceutical development.
• Knowledge of European Regulatory requirements for clinical trial applications.

Aufgaben

• Proactively communicate European regulatory strategies to the Country Cross Functional Teams.
• Explain market-specific conditions and needs with regard to European regulatory strategies to European and Global Regulatory Teams.
• Serve as the main regulatory contact with German authorities (BfArM/PEI) and other supervisory bodies.
• Ensure compliant implementation of launches and ongoing updates to Marketing Authorisations and SMPCs/PILs.
• Collaborate with Pharmacovigilance and Medical departments on DHCP letters and RMP materials.

Kenntnisse

German regulatory knowledge

AMNOG process

Regulatory strategy support

Health Authority interaction

Drug development knowledge

European CTA regulations**

Ausbildung

Scientific degree in Medical/Pharmaceutical/Natural Sciences

Jobbeschreibung

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 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, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to 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. 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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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.