Regulatory Affairs Specialist

1 month ago


Uxbridge, United Kingdom Biotech 365 Full time

At Biotech 365, we are seeking a skilled Regulatory Affairs Specialist to join our team in Uxbridge. This contract role will last for 12 months and offers an hourly rate of up to £35.00 per hour (PAYE) inside IR35.

Job Summary:

The successful candidate will lead and manage the procedural and operational aspects of European regulatory filings within the European Centralised Procedure. This will involve working closely with the European Regulatory Liaison group and other regional and global functions.

  • 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.
  • Work 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.
About Us:

Biotech 365 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. Our goal is to put patients first and help people live better and healthier lives.

Salary:

This role offers an estimated annual salary of £29,280 - £71,040, based on a 50/50 hybrid working model.



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