Job Detail

Wir schaffen innovative Arzneimittel für Patienten, die ernsthafte Krankheiten bekämpfen. Wir bilden unser eigenes, vielfältiges Team mit inspirierender Arbeit und herausfordernden Karrieremöglichkeiten. Egal in welcher Rolle, jeder von uns leistet seinen Beitrag. Und das macht den Unterschied aus.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular,immunoscienceand fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Key Responsibilities and Major Duties:

• Implement the regulatory vision and provide high quality, strategic leadership in executing regulatory activities in Switzerland, linking commercial strategies to filing plans in the decision making process


• Act as key partner to the commercial and medical functions in BMS Switzerland. Seek opportunities for timely, accelerated, and effective regulatory submissions


• Drive effective and consistent communications with Swiss Health Authorities and explore innovative regulatory practices. Drive regulatory processes in line with business and research & development objectives to ensure timely registration of new products, line extensions, and life cycle management of BMS products, and as such, obtain marketing authorizations for medicinal products with high medical need


• Interact with Swiss Regulatory Authorities regarding clinical trials applications (CTAs) in line with BMS company policies and practices as well as local legislation


• Support launch activities and provide key pre-launch support. Apply effectively processes and quality standards for advertising and promotion review and approval in line with BMS policies


• Act as a key partner to the country medical, pharmacovigilance, market access, and marketing departments, global GRS functions and GMS in the management of the life of the marketed products


• Develop the necessary external network with Health Authorities and Trade Associations in Switzerland


• Contribute to a high performing organization and culture by developing and performing in a strong regulatory team

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Requirements:

• University degree, ideally a Master's of Science or PhD degree, preferably in medical, pharmaceutical, or other life sciences or the equivalent in relevant work experience


• Experience in leading country regulatory activities, including: marketing authorization and clinical trial submissions, life-cycle management activities, pre-launch and launch activities support, health authority interactions in Switzerland


• Competencies
  
  
  
  • Expertise in a regulatory function in the country, ensuring compliance and alignment with both R&D and country objectives
  
  
  • Proven track record implementing working systems and processes and implementing plans to achieve superior execution and to provide customers / patients the highest-quality pharmaceuticals
  
  
  • Demonstrate success as a credible, influential, and respected spokesperson able to develop effective cross-functional partnerships
  
  
  • Exposure to international regulatory environment
  
  
  • Proven ability to navigate effectively in a multi-cultural environment with the ability to communicate across all levels and functions of a global organization
  
  

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular,immunoscienceand fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Key Responsibilities and Major Duties:

• Implement the regulatory vision and provide high quality, strategic leadership in executing regulatory activities in Switzerland, linking commercial strategies to filing plans in the decision making process


• Act as key partner to the commercial and medical functions in BMS Switzerland. Seek opportunities for timely, accelerated, and effective regulatory submissions


• Drive effective and consistent communications with Swiss Health Authorities and explore innovative regulatory practices. Drive regulatory processes in line with business and research & development objectives to ensure timely registration of new products, line extensions, and life cycle management of BMS products, and as such, obtain marketing authorizations for medicinal products with high medical need


• Interact with Swiss Regulatory Authorities regarding clinical trials applications (CTAs) in line with BMS company policies and practices as well as local legislation


• Support launch activities and provide key pre-launch support. Apply effectively processes and quality standards for advertising and promotion review and approval in line with BMS policies


• Act as a key partner to the country medical, pharmacovigilance, market access, and marketing departments, global GRS functions and GMS in the management of the life of the marketed products


• Develop the necessary external network with Health Authorities and Trade Associations in Switzerland


• Contribute to a high performing organization and culture by developing and performing in a strong regulatory team

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Requirements:

• University degree, ideally a Master's of Science or PhD degree, preferably in medical, pharmaceutical, or other life sciences or the equivalent in relevant work experience


• Experience in leading country regulatory activities, including: marketing authorization and clinical trial submissions, life-cycle management activities, pre-launch and launch activities support, health authority interactions in Switzerland


• Competencies
  
  
  
  • Expertise in a regulatory function in the country, ensuring compliance and alignment with both R&D and country objectives
  
  
  • Proven track record implementing working systems and processes and implementing plans to achieve superior execution and to provide customers / patients the highest-quality pharmaceuticals
  
  
  • Demonstrate success as a credible, influential, and respected spokesperson able to develop effective cross-functional partnerships
  
  
  • Exposure to international regulatory environment
  
  
  • Proven ability to navigate effectively in a multi-cultural environment with the ability to communicate across all levels and functions of a global organization
  
  

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 the resources to pursue their goals, both at work and in their personal lives.