Regulatory Compliance Expert

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.

**In Aubonne's team, you will**:
Ensure alignment between regulatory requirements and site GMP documentation as well as coordinate site Regulatory Compliance activities with the different site partners while providing local regulatory expertise and be the local point of contact for Global Regulatory Affairs and for Health Authorities. You will also provide deliverables for regulatory submissions, registrations, renewals, and Answers to Objections. Finally, you will perform the regulatory assessment [KS1] of change controls and be involved in the regulatory and implementation strategy of key projects and variations while actively participating in the improvement of the processes of Site Regulatory Compliance and be responsible for writing and updating the site regulatory documentation.

**Functional Knowledge**:

- Minimum 3 year expertise and knowledge in Regulatory Affairs proven by relevant educational or professional background
- Good knowledge in biotechnological sciences and manufacturing of biologics
- Knowledge and experience in current Good Manufacturing Practices (GMP)
- Able to search, understand and interpret regulatory intelligence information and regulatory guidelines
- French (C1 level) and english (B2)
- Rigourous, analytical, good writing and communication skills

**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