Senior Regulatory Affairs Specialist

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Location

Europe / Middle East / Africa, United Kingdom, Reading, Berkshire

Hybrid (Work from Office and Remote)

Reporting

Senior CMC Manager

Job Overview

The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.

What You Will Do

• Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.
• Collects and evaluates information on regulatory require...