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Senior Manager CMC Dossier Leadership (all genders)
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.
You are responsible in this role to lead and drive CMC regulatory activities, lead the CMC dossier content and interaction with CMC technical functions for New Chemical Entities from Phase I, II, III until launch (incl. Phase IV). This encompass responsibility for the CMC section of the CMC strategy document and contribution to risk and gap assessment, strategic support and advice. Furthermore, you contribute to Health Authority interactions on CMC regulatory topics and activities 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 (“CMC Dossier”). Furthermore, you are participating in Health Authority Meetings as appropriate. You are responsible for translation and interpretation of the country regulatory requirements into CMC/technical requirements and to provide them as prospective advice to the CMC technical functions such as for example analytical development of drug substance and drug product, formulation development of drug product, drug substance development, and others e.g. non-clinical development. You are securing the CMC Regulatory Compliance for the development projects and being responsible for performance/preparation of regulatory compliance audits/inspections at the sites including CMOs.
In addition, you perform an expert assessment of in-and out licensing projects for business development (Due Diligence) and being a permanent member in CMC project teams, dossier generation team, other international and interdisciplinary working groups.
Who you are:
- University degree in pharmacy or life sciences, Ph.D. beneficial
- Minimum of 7 years of pharmaceutical industry experience, with at least 3 years of global CMC regulatory experience
- Excellent communication skills including interaction with all levels of the organization
- Professional experience in pharmaceutical development, analytical development, drug substance and drug product synthesis and/or global CMC regulatory affairs
- In depth knowledge of pharmaceutical legislation including pharmacopeial requirements for the pharmaceutical areas
- Experience in working with electronic document management systems
- Excellent written and spoken communication skills in English (knowledge of other European languages is an asset)
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