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A career at our company is an ongoing journey of discovery: our around 52,000 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 will ensure CMC dossiers of the site commercial and development products are consistent and compliant with the site activities and will coordinate the site review of quality (Quality/CMC) sections for clinical trials applications or worldwide submissions.
Part of the job is to ensure Quality/CMC consistency and compliance by liaising with the Global Regulatory Affairs department. You will support the establishment of Regulatory reporting (e.g. Annual Reports) and Regulatory Affairs requests (e.g. renewals process, statements, GMP certificates). You will also coordinate the evaluation of new regulatory / cGMP publications / pharmacopeias and their implementation within the site. Your responsibilities will include to be involved in the management the Change Control Proposals (CCPs) from a regulatory perspective. and will provide the regulatory status overview for products portfolio to the Qualified Person of the site in the frame of product disposition process.
You will take part to the site Quality inspections readiness program and to compliance audits on Regulatory Quality/CMC dossier.
•Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
•You have at least 3-5 years of experience in the pharmaceutical industry
•You have at least 3-5 years of experience in global CMC regulatory affairs, and quality assurance / compliance
•Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, or International)
•Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or a large variation
•Good knowledge in biotechnological sciences, manufacturing of biologics and related regulatory guidelines (cGMPs, 21 CFR, etc.)
•Able to search, understand and interpret regulatory intelligence information
•Autonomous, highly adaptable, able to collaborate and deliver in a matrix environment
•Excellent written and spoken communication skills in English
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