Regulatory Affairs Manager, Pre-Approval, Regulatory Submissions, Pediatric Drug Development
Your new company
As one of the leaders in the pharmaceutical and biotech industries, joining this company gives you an opportunity unlike any other. With unparalleled opportunities across various therapy areas and on a global scale, you will be joining the company as Regulatory Affairs Manager doing work across Paediatric submissions. This role will be based in Dublin, Ireland and be open to EU/UK applicants.
Your new role
Your new role as Regulatory Affairs Manager will be part of the wider Regulatory Affairs team working more specifically across Paediatric drug development. This role gives you the opportunity to take on board work across early-stage developmental Regulatory Affairs on a global scale. You will be communicating and working with key Regulatory bodies and health authorities across the US, EU and other Global regions in order to ensure these investigational procedures are completed to the highest degree. A background in early-stage drug development is particularly key as you will have a high level of responsibility.
What you'll need to succeed
- An established background in pharmaceutical Regulatory Affairs
- Early-stage developmental knowledge in authoring Regulatory submissions (Essential)
- Technical experience working across Paediatric product development processes (Desirable)
- Direct communications and negotiations experience with Regulatory bodies and key stakeholders
- Global market knowledge across EU, US, and other International markets
- Highly strategic technical skills in Regulatory strategy development
- Degree in a scientific field
What you'll get in return
You will get the opportunity to work across the technical side of Regulatory Affairs every professional within the industry strives to get into. Additionally, you will be compensated generously for the high level of skill required behind the role, and even be offered ample progression opportunities.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
- Regulatory Submissions
- Regulatory Affairs Manager
- Pediatric Drug Development
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