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Senior Regulatory Project Manager
hace 5 horas
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**
- ** Global Regulatory Planning**: Responsible for regulatory functional planning and tracking deliverables for submissions to health authorities worldwide.
- ** Project Plan Creation**: Develops plans for initial submissions such as CTA/IND, MAA/NDA/BLA, and significant meetings with regulatory authorities.
- ** Strategic Collaboration**: Works closely with the Global Regulatory Lead and Submission Manager to define and execute the submission strategy.
- ** Submission Execution**: Accountable for the execution of submissions to health authorities, including the Submitter role for submissions via the CTIS portal in the EU.
- ** Crisis Management and Budget**: Intervenes in crises impacting project timelines and consolidates budget demand as a key contact for global project management.
- ** Leadership and Continuous Improvement**: Leads the Submission Task Force and co-chairs the International Submission Taskforce, managing regulatory activities and improving project management tools.
**Who you are**
- Bachelor's Degree with 5-8 years of experience OR Master’s degree with 3-6 years of experience or Ph.D wit 2-5 years of experience.
- Experience in a Regulatory environment.
- Experience in project management and technology solutions
- ln-depth knowledge and experience in own discipline and beyond
**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
