Regulatory Affairs Manager

South East England Temporary Hybrid working
  • Fantastic opportunity to join an innovative biopharmaceutical company
  • Developing and manufacturing market leading Vaccines

About Our Client

The Client are an innovative biopharmaceutical company working on development and manufacturing of market leading vaccines.

Job Description

As a Regulatory Affairs Manager on an initial 12 months contract you will be:

  • Preparing and maintaining national labelling
  • Preparing dossiers to meet national submission requirements for new licences, licence renewals, variations, PSURs and DSURs
  • Maintaining national aspects of global regulatory systems
  • Reviewing global SOP's and assessing their impact on local processes
  • Maintain national distribution licences and participate in GDP inspections as required
  • Serving as a Subject Matter Expert oat a national level

The Successful Applicant

To be successful as a Regulatory Affairs Manager, you will have experience with:

  • Labelling preparation - checking leaflets, packaging, SmPCs, print releases, etc.
  • EU / UK Regulatory submissions processes - new licences, variations, renewals
  • Working with different types of licences - MR, DC, Centralised, National
  • Working with MHRA
  • Brexit & GB requirements

What's on Offer

This is an exciting company to work for in a remote role with a competitive rate of pay, on a 12 month contract.

Contact
Jamie-Lee Debenham
Quote job ref
JN-082023-6148587
Phone number
+44 172 773 0114

Job summary

Job function
Life Sciences
Subsector
Regulatory Affairs
Sector
Healthcare / Pharmaceutical
Location
South East England
Contract type
Temporary
Consultant name
Jamie-Lee Debenham
Consultant phone
+44 172 773 0114
Job reference
JN-082023-6148587
Job Nature
Hybrid working