European Regulatory Affairs Specialist

1 month ago

London, Greater London, United Kingdom CK Group Full time
European Regulatory Procedural Strategist Role Overview

The European Regulatory Procedural Strategist (ERPS) team plays a crucial role in managing the procedural and operational aspects of European regulatory filings within the Centralised Procedure. This involves close collaboration with the European Regulatory Liaison group and other regional and global functions.

Key Responsibilities:
  • Manage operational and procedural aspects and provide support for new Marketing Authorisation Applications preparation and filings and Life Cycle Management for the Centralised Procedure.
  • Plan and track activities related to regulatory submissions in the EU.
  • Communicate regulatory submission dates, regulatory status, nature of changes, track and inform of minor/significant product information changes to all relevant parties.
  • Provide logistic support for meetings with the European Medicines Agency (EMA) and national Health Authorities and other related meetings in connection to assigned projects.
  • Work together with the European Regulatory Liaison (ERL) in the development process of the European strategy through research (competitors, guidelines) and membership of multidisciplinary Project Teams.
Your Background and Skills:

To be successful in this role, you will need a solid scientific background and at least 3 years of direct (or relevant) hands-on experience in European regulatory procedures. Great communication, organisation, and attention-to-detail skills as well as in-depth knowledge of EU Regulatory requirements are essential.

The successful candidate will be able to work on LCM and MAA with minimum supervision, support early projects, and take a leadership role in non-project-based support.

About the Client:

Our client is a global leader in enabling pharma, biotech, and consumer health partners to optimise product development, launch, and full life-cycle supply for patients around the world. They put patients first and strive to help people live better and healthier lives.

This role is based at the client's site in Uxbridge with 50/50 hybrid working. It is essential that applicants hold entitlement to work in the UK.

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