Regulatory Compliance Lead (all genders)
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:
As the Site Regulatory Compliance Lead, you will be instrumental in ensuring regulatory adherence across our multidisciplinary projects, including product launches and technical changes. Acting as the primary regulatory contact, you will collaborate closely with various internal departments, such as MSAT, Production, QA, QC, and Engineering. Your responsibilities will include evaluating site change controls and ensuring timely communication with the Swiss Authority, which is crucial for the submission of regulatory documentation. This role is vital for fostering compliance and facilitating effective communication across diverse regulatory landscapes. You will track amendments and regulatory assessments, coordinate the writing of registration dossiers, and manage deadlines to ensure timely regulatory submissions. Additionally, you will serve as a key point of contact for health authorities, providing necessary data and responses to inquiries. You will actively participate in the preparation for inspections and audits, ensuring our readiness and compliance. By leading internal audits and contributing to corporate and continuous improvement projects, you will help shape our regulatory landscape.
Who you are:
- You hold a degree in Pharmacy or Life Science, Biotech, Medical, PharmD, or a related discipline (minimum M. Pharm or MSc or equivalent degree); a higher degree (e.g., PhD) is preferable.
- You have at least 7 years of experience in Regulatory Affairs, focusing on medicines (new, generic, similar, and biological).
- You are fluent in both English and French.
- You possess strong analytical, strategic, and conceptual thinking skills.
- You are an influential and proactive individual with excellent interpersonal relationship skills.
- You have experience with regulatory systems such as Veeva Vault.
- You can manage multiple projects and meet tight deadlines effectively.
- Your communication skills, both written and verbal, are exceptional.
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!
Segment de l’offre d’emploi:
Neurology, Oncology, Biology, Biotech, Pharmacy, Science, Healthcare