A career is an ongoing journey of discovery: our 51,000 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.
Prepare global regulatory strategies for projects. Manage submission and approval of applications for clinical trials (WW) and registrations (WW), full submissions and variations in 3 ICH regions. Represent the company in external forum, in co-development joint committees, and GRA in Global Project Teams. Lead GRA sub-team depending on development status of projects. Manage the regulatory submission process from pre-submission health authority interactions through to approval including management and coordination of the preparation of all regulatory documentation. Manage the regulatory agency interactions, document preparation, co-ordination rehearsals, minutes, and ensure the impact for the project is transferred to the Project Team. Review of clinical study protocols, study reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs and CTD (development and registration status). Be open for new innovative regulatory pathways to accelerate the overall development.
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
- Team collaboration is a key competence
What we offer: 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