Regulatory Affairs Manager

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.

• Drive in country/s submission management of innovative medicinal products from planning to finalizing local submissions (incl. review & approval of dossiers, new documentation for label & artwork when applicable).
• Manage specific local Module 1 requirements (including National leaflets, Artworks, mock- ups when applicable) & manage country input and fees planning.
• Language dependent activities (Cover letter, Artworks & promotional materials management, Modul 1, National PI..).
• Support Named Patient Programs Early Access Programs for new assets.
• Serve as point of contact for Health Authorities to maintain close relationships.
• Drive local cross-functional alignment & quality control of regulatory applications/ documentation (dossier if applicable, promotional material) with regional/local regulatory requirements
• Implement country product plans based on global/regional strategy and business plans.
• Communicate with partners & key local stakeholder functions.
• Enable documentation & communication of regulatory intelligence.
• Contribute with Regulatory Affairs input for cross-functionally crisis management such as quality alerts stock-outs and maintain HA interaction.
• Provide relevant support for clinical trials as applicable.
• Coordinate day-to-day operations for respective country.
• Review and approve promotional and medical materials.
  
  

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!