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:
The Senior Specialist/ Expert License Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work.Ability to contribute to the dossier content and to perform content and quality review on regulatory documentationAbility to develop and prepare successful regulatory strategies and dossiers.Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team leadAbility to provide Regulatory expertise into the planning and execution of projects and tasksAbility to work within a matrix organisation, build relationships with internal or external stakeholder
Who You Are:
8-12 years of work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variationsExperience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirementsIn Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategiesStrong project management and documentation skills, proactive communication approachContributor level experience with RIM and EDMS RA applications.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!