Description
Senior Director/Director Regulatory - Biologics Expert - Full Lifecycle - Up to £90,000 - South East EnglandSenior Director/Director Regulatory - Biologics Expert - Full Lifecycle - Up to £90,000 - South East England
Basic Salary
Annual Bonus
Pension
Healthcare
Other benefits
We are currently working with one of the leading global CRO's who are looking for a strong biologics expert to join the team. This company work with biopharmaceutical and other life science companies to improve the probability of their client's success. They bring an industry recognized depth of expertise and breadth of perspective to shape better ideas. With thousands of employees working in about 100 companies, they have helped to develop some of the best-selling drugs on the market in 2013.
They are currently looking for an experienced regulatory biotech/biological expert. This person should be able to handle not only standard biotechnology but also emerging areas, such as nanotechnology and advanced therapies (ATMP).
Key competencies for the role are:
- PhD in a natural science, PharmD or MD experience
- Experience with large molecule CMC is required and with advanced therapies is desirable.
- Experience in providing strategic and operational support in drug development programmes
- Experience at a Senior or Executive level in Regulatory Affairs in a CRO, regulatory agency or global biopharmaceutical organisation
- Experience in the EU or US with FDA or EMA is required. Global experience with regulatory authorities and submissions directly or indirectly ex-US/EU is desirable.
- Demonstrated pro-active approach in working/communicating with relevant stakeholders such as Regulatory Agencies
- Experience with companion diagnostics is highly desirable.
- Biotechnology and biosimilar company track-record is highly desirable.
If this is of interest to you and you would like to find out more information on this position or any other regulatory affairs positions, please contact Amanda Edwards on or please email a.edwards(a)realstaffing.com