Manager, Regulatory Affairs, EU - Central London
Hendre Moolman is recruiting for a Manager of Regulatory Affairs to join an innovation-driven global phamaceutical company at their site in Central London on a 6 month contract.
Our client is a patient-focused, values-based, R&D-driven global pharmaceutical company with an extensive history of providing life-changing treatments for patients.
This role is located in Central London. Easily accessible from London and surrounding areas.
Your main duties will be to:
- Manage and execute all regulatory activities of all levels of complexity for various projects.
- Ensure that all documents for regulatory applications are prepared in accordance with company SOPs, GCP and other guidelines.
- Provide a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
Further responsibilities will include:
- Manage all relevant submissions and approvals.
- Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
- Direct point of contact with health authorities on general issues.
The ideal candidate for this role will have:
- Minimum of a scientific degree.
- Proven regulatory experience gained within the pharmaceutical industry.
- Experience in reviewing, authoring, or managing components of regulatory submissions.
- Experience as primary liaison to regulatory authorities and in handling Agency meetings.
- Basic working knowledge of drug development process and regulatory requirements.
- Good understanding of GCP and other relevant practices.
For more information or to apply for this position, please contact Hendre Moolman on 01438 842970 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45396 in all correspondence.