Description
Regulatory Portfolio Project Manager - Biologics and Drug Development - Global Biotech - Up to £75,000 basicRegulatory Portfolio Project Manager - Biologics and Drug Development - Global Biotech - Up to £75,000 basic
Basic salary: Up to £75,000
Annual bonus: 10%
25 days holiday
Pension
Healthcare
We are currently working with a leading global Biopharmaceutical company who are looking to expand their regulatory affairs team. This is due to the increasing demand of new and exciting projects entering into the company's pipeline and therefore they are looking for another high level regulatory professional to join them. They need a new Regulatory Affairs Project Manager to lead the development of projects and drive the global regulatory strategy. You will concentrate on full product lifecycle development and work on products in various phases. This is a global lead role with the requirement for a confident and strong personality.
Key skills/Requirements
- Strong regulatory global experience (European experience as a minimum)
- Any experience with the FDA desirable
- Experience of early phases of drug development (e.g. Phase I, II)
- Biologics development experience
- MAA/BLA/NDA filing preparation experience
- Ability to lead a cross-functional team for regulatory deliverables e.g., leading the preparation and conduct of agency scientific advice meetings
You will need to be capable of leading a global regulatory project both in terms of defining strategy but also in terms of implementation, either by directly or indirectly.
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