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Global Regulatory Affairs Oncology, Strategist (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.
Your role: The Strategist for Global Regulatory Affairs (GRA) Oncology develops and prepares regulatory strategies for projects. It manages submission and approval of applications for clinical trials (WW) and marketing applications, full submissions and variations in 3 ICH regions. In addition, the role represents the company in external forums and in co-development joint committees. Internally the role works as representative for GRA in Global Project Teams. The role manages the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation. As strategist you will manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes. The role manages in addition the Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs and CTD (development and registration status) and leads a GRA sub-team.
Who you are:
- Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, Degree in pharmacy or medicine)
- Minimum of 8 years’ industry experience of which at least 6 years’ regulatory experience
- Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
- Experience with regulatory agency interactions and preparation of documentation to support interactions
- Experience in NCE and NBE drug development
- Excellent spoken and written 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