Senior Manager, Global Regulatory Affairs CMC (all genders)

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role

As the Senior Manager Regulatory CMC, you will be at the forefront of shaping our regulatory landscape. You will represent the Global Regulatory Affairs CMC group, providing invaluable guidance to internal teams, including Global Regulatory Strategy, CMC, technology transfer, manufacturing launch, and global supply chain. Your expertise will drive all CMC regulatory activities, as you take ownership of the CMC dossier Strategy Document, ensuring the highest quality and strategic decision-making for submissions worldwide. You will lead the development of the Global Regulatory CMC strategy for Life Cycle Management programs, focusing on proactive risk assessment and mitigation. Additionally, you will engage with Health Authorities, interpret country-specific regulatory requirements, and review emerging laws and guidance, positioning us as leaders in a competitive market.

Who you are

• You bring a wealth of experience with at least 5 years in regulatory CMC, showcasing your ability to craft and execute successful CMC strategies and dossiers.
• Your hands-on experience includes managing and authoring regulatory CMC documentation for comprehensive international submissions or significant variations.
• You have a solid background in life-cycle management activities across at least two regions, such as Europe and the USA, with additional international exposure being a valuable asset.
• Your practical experience spans manufacturing process development, transfers, validation, or analytical development and control strategies.
• You possess a deep understanding of global pharmaceutical legislation and its implications.
• You have exceptional  written and spoken communication skills in English (knowledge of any other European languagues is an asset such as French, Italian or German)
• You are known for your strong interpersonal skills and flexible mindset, paired with a meticulous attention to detail.
• With a strategic mindset, you thrive in collaborative team environments and excel in project management, all while demonstrating outstanding organizational and planning abilities.

This position can be filled either in Eysins or Vevey.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!