Manager Regulatory Sciences Switzerland

Profile

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, immunoscience and 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.

Company: Bristol-Myers Squibb

Req Number: R1524830_EN

Updated: 2020-05-07 00:00:00.000 UTC

Location: Cham,Switzerland

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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