Description
Regulatory Affairs Project Manager - High Priority GroupLocation: You can commute from London, Cambridge, Essex area
Salary: £48,000 - £55,000 + 15% Bonus and PackageOverview: Would you like to work in a role focused on submission of new Marketing Authorisation Applications for some of our most important generic retail products globally.
If you are looking for Regulatory Affairs Project Manager role working within the European Regulatory Affairs Team based in our office in the EU headquarters. This working for one of the biggest pharmaceutical companies in the UK and among the top 15 pharmaceutical companies globally. Skills & Experience
To be considered for this role you will have the following skills and experience:
- A degree (or equivalent) in a Life Sciences or Pharmacy related subject
- Previous CMC experience (or a demonstrated technical aptitude) and the ability to understand and critically evaluate the scientific content of Marketing Authorisation Applications
- Experience working within Regulatory Affairs including practical experience of European submission procedures
- A detailed understanding of European regulatory requirements and guidelines
- Existing line management experience would be an advantage
Reporting to the European Regulatory Affairs Manager for High Priority Developments you will have overall regulatory responsibility for your assigned projects. This is a broad, challenging and high profile role giving you direct exposure to all stages of the development process. This will include:
- Compiling and submitting new Marketing Authorisation Applications via the Decentralised Procedure and the Mutual Recognition Procedure
- Working with R&D experts to optimise the scientific content of all dossiers
- Sitting on multidisciplinary project teams to provide strategic input on key regulatory considerations
- Preparation and submission of responses to Health Authority questions
- Preparation and submission of critical pre-launch post approval variations
For more information please contact our Regulatory Team Manager Natalie Hopkins with your updated C.V at n.hopkins(a)realstaffing.com or call on for more information