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…