Manager Regulatory Cmc F/m

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**:
Your role involves developing and managing the Global Regulatory CMC strategy for assigned projects/products across various regions. Responsibilities include overseeing regulatory CMC activities to ensure timely delivery and quality compliance, as well as authoring and maintaining the CMC Dossier Strategy Document and related registration dossier (NDA/MAA, variations, etc.). The role will provide regulatory CMC expertise to key stakeholders, ensuring adherence to country-specific requirements and evaluating Change Control proposals.

Given the significant business impact and dynamic life-cycle management environment, your role is high-demand, and fast-paced. It involves managing critical business topics, necessitating resilience and learning agility.

The role requires international travels for business meetings, visit of manufacturing sites for key stakeholder interactions and technical meetings.

**Who you are**:

- You have a Degree in a Life Science or related discipline (e.g., MSc or equivalent degree; PhD in a scientific discipline is preferred), a minimum of 5 years of pharmaceutical industry experience, with at least 2 years of experience in Global regulatory affairs (GRA) related to Chemistry Manufacturing and Control (CMC).
- You possess a strong ability to develop and prepare successful regulatory CMC strategies and dossiers.
- You have extensive experience in the preparation and management of regulatory CMC documentation, including full international submissions and large variations.
- You hold practical experience in manufacturing process development, transfers, validation, or analytical development and control strategies.
- You have in-depth knowledge of global pharmaceutical legislation and regulatory affairs.
- Your excellent written and spoken communication skills in English are complemented by knowledge of other European languages, such as French and German.
- You are strategic in your thinking, detail-oriented, and possess excellent organizational and planning skills.

**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