European Regulatory Procedural Strategist

1 month ago

London, United Kingdom CK Group Full time
CK Group are recruiting for a European Regulatory Procedural Strategist, to join a global pharmaceutical company, based in Uxbridge on a contract basis for 12 months.


Salary:

Hourly rate - up to £35.00 per hour (PAYE) inside IR35


European Regulatory Procedural Strategist Role:

The European Regulatory Procedural Strategist (ERPS) team leads and manages the procedural and operational aspects of the European regulatory filings within the European Centralised Procedure, working in close collaboration with the European Regulatory Liaison group and the appropriate regional and global functions.
  • Manages the operational and procedural aspects and provide support for new Marketing Authorisation Applications preparation and filings and also Life Cycle Management for the European Centralised Procedures.
  • Plan and track activities related to regulatory submissions in the EU.
  • Systematic communicator of 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 EMA and national Health Authorities and any other related meetings in connection to the assigned project.
  • Working together with the European Regulatory Liaison (ERL) in the development process of European strategy through research (competitors, guidelines ) and membership of multidisciplinary Project Teams (including with business), as necessary.

Your Background:
  • Solid scientific background (PhD level desired).
  • At least 3+ years of direct (or relevant) hands-on experience in European regulatory procedure.
  • Work on LCM (lifecycle management) and MAA (marketing authorisation application) with minimum supervision, support early projects, take leadership role for non-project based support.
  • Great communication, organisation and attention-to-detail skills as well as in depth knowledge of EU Regulatory requirements are clear specificities and a must for the job.


Company:

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

Location:

This role is based at our clients site in Uxbridge, with 50/50 hybrid working.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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