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Sr Manager Reg CMC Compliance - Biotech
A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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 concerned molecules of specific focus area (NBEs and marketed products). This encompass responsibility for the CMC section of the CMC strategy document and contribution to risk assessment, strategic support and advice. Provide support during Health Authority interactions on CMC reg. topics. Activities include e.g. the CMC regulatory/dossier strategy, strategic planning in collaboration with Global Regulator 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. Secure CMC Regulatory Compliance for the products. Be responsible for the creation of the quality reference files for products under own responsibility. Responsible for performance/preparation of regulatory compliance audits/inspections at the sites including CMOs. Provide profound expertise in pharmaceutical legislation and application of current regulatory landscape including pharmacopeia requirements for the pharmaceutical areas. Expert assessment of in-and out licensing projects for business development (Due Diligence)
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 early development through life cycle managment and at least 3 years of global CMC regulatory experience
- Broad knowledge of regulatory requirements for CMC (EU, US, ICH and other relevant guidelines)
- Broad knowledge of EU and US Pharmacopoeias and GMP regulations
- English fluent
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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!
Curious? Apply and find more information at https://jobs.vibrantm.com