Regional Regulatory Lead (all genders) - Oncology

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: 

• Represent and provide input for your respective region at the Global Regualtory Sub Team (GRST). May provide direct input to the Global Program Team (GPT) in case of major region, particularly where the Global Regulatory Lead (GRL) is not in that region.
• Lead the respective regional regulatory sub-team.
• Drive the regulatory submission in your respective region. Ensure optimal planning inalignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management.
• May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this case.
• Contribute to the global regulatory strategy with local / regional strategy for assigned projects.
• Matrix leadership role of respective Regional Regulatory ST.
• Participate in cross-functional and GRA initiatives.
• Manage submission planning and ensure timely, compliant execution of both development and maintenance submissions. 
• Solid understanding of regulatory strategy development, with the ability to partner with regulatory project management and submission management teams to ensure strategic alignment and successful submission execution.
• Interaction with global regulatory teams (GRST) and  contribution to our global regulatory strategy while aligning with regional needs, demonstrating an understanding of the local regulatory landscape and its impact on global initiatives. 

Who you are:

• Advanced degree (Master’s, PhD, or equivalent) in a relevant field such as Life Sciences, Pharmacy, or Regulatory Affairs, with at least 3 years of experience in drug development, particularly in regulatory affairs. 
• Experience in a regional or global regulatory leadership capacity is highly desirable and in regulatory submissions for major health authorities, such as the FDA, EMA, and other regional agencies. 
• Demonstrated experience in leading cross-functional teams and matrix leadership, with a proven ability to drive collaboration and influence stakeholders across different regions and functions, especially in the context of regulatory submissions, development, and maintenance. 
• Strong communication skills in both spoken and written English, with experience leading direct interactions with local health authorities (e.g., FDA, EMA) and contributing to global regulatory strategy while incorporating local/regional nuances and requirements. 
• Proven ability to lead matrix teams effectively, particularly within regional regulatory sub-teams, ensuring both execution and compliance with regulatory requirements and standards. 
• A proactive and solution-oriented approach, with a willingness to take ownership of key tasks and provide guidance to the team, ensuring successful and compliant project outcomes.

Location: Europe

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!