about 2 months ago
Job title: Regulatory Affairs Director - Global Neuroscience
A global biopharmaceutical company in Berkshire are seeking a Regulatory Affairs Director to work within their Global Neuroscience portfolio. This role will be responsible for two early phase products with the focus on brining these to market over the coming years. The ideal candidate will have over ten years' experience within regulatory affairs with a particular focus on clinical stage activities.
- Leading strategy, tactics and implementation of all regulatory aspects for assigned products
- Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards).
- Ensure regional regulatory specificities and needs are incorporated into the global plans through collaboration with local and intercontinental Regulatory Affairs where available.
- Provide regulatory input into the integrated development plan. In collaboration with other research & development departments, define the optimal plan to reach the target product profile
- Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs
- Significant early phase development experience. Ideally with Biologics/Sterilises
- Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
- Experience across a global remit - including Japan and China markets
Salary and benefits:
A highly competitive salary, annual bonus, car allowance and wider benefits scheme is on offer
To apply for this position or hear further details then please contact Matt Thomas via email@example.com