Description
A global Pharma based in the South-East of England require a Regulatory Affairs Manager to join their Worldwide Safety and Regulatory team.This is an exciting opportunity to join a global Pharma with one of the largest product portfolios on the market on an initial 12 month contract as a Regulatory Affairs Manager in their European Regulatory Affairs team.
The successful candidate will;
- Obtain, manage and maintain product Marketing Authorisations (MAA) and Clinical Trial Authorisations (CTA) in line with business goals and legal requirements
- Conduct associated regulatory activities for the specified European markets
- Contribute to implementation and leading of projects, and building of expertise within the Regulatory Department
- Provide Regulatory advice and information to meet customer and cross-divisional colleague requests
- Manage and submit Marketing Authorisation Applications (MAA) to national/MRP/DCP/CP
- Manage and submit MA variation applications
- Manage and submit MA renewal applications
- Influence Regulatory Authorities
- Manage Clinical Trial Approvals
- Populate and maintain Regulatory Databases
- Obtain Authority Approvals for supply of unlicensed medicines
- Safeguard compliance and manage packaging and prescribing information component updates (artwork, SmPC, PIL, labelling components)
- Implement MA divestments, cancellations and product discontinuations
- Contribute to good Regulatory practice
- Support Regulatory Affairs group development
- Provide support to Third Party Licences
Essential experience:
- Relevant life science or chemistry graduate to honours level or equivalent (Masters Degree, Postgraduate Diploma or PhD preferred)
- Relevant professional qualifications highly desireable (MSc in Regulatory Affairs)
- Previous hands on experience in Regulatory Affairs, particularly in European markets
- Member of TOPRA preferred
- Demonstrated computer literacy
- Excellent written and verbal communication skills
- Proven strength in analytical thinking
If you would like to hear more about this role please do not hesitate to contact Colm Tobin at Real Staffing on .