A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: Lead and drive CMC regulatory activities: lead the dossier content and interaction with CMC technical functions for specific biological molecules (NBEs). Responsible for the CMC section of the CMC strategy document and contribution to risk assessment, strategic support and advice. Activities include e.g. the CMC regulatory/dossier strategy, strategic planning in collaboration with Global Regulatory Affairs, authoring, review and approval of all regulatory relevant quality documents. Be accountable and responsible for translation and interpretation of the country regulatory requirements into CMC/Technical requirements to provide them as prospective advice to the interdisciplinary CMC team. Secure CMC Regulatory Compliance for the products. Provide profound expertise in pharmaceutical legislation and regulatory guidelines applicable to drug development (IND/IMPDs) and new biological applications (BLA/MAA). Provide support during Health Authority interactions on CMC reg. topics. Provide expert assessment of in-and out licensing projects for business development (Due Diligence). Act as Director’s deputy, endorse leadership behaviors that cultivate collaboration, assist the Director in coaching and developing the skills of the group members.
Who you are:
- Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
- Minimum of 7 years of pharmaceutical industry experience with strong focus on biological entities from development (phase I, II, III clinical trials) through life cycle management and at least 5 years of global CMC regulatory experience
- Broad knowledge of CMC regulatory requirements for biologics (EU, US, ICH and other relevant guidelines)
- Profound knowledge in GMP regulation and pharmaceutical disciplines: analytical testing, pharmaceutical technology and drug development
- Excellent written and spoken communication skills in English
What we offer: We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!