Browse by job sector

EMEA Regulatory Affairs

  1. East Anglia
Buckingham
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
34584

This vacancy has now expired

EMEA Regulatory Affairs Contract or- Pharmaceuticals - 6-Month Contract

Our client have an exciting new opportunity for a regulatory affairs contractor to join the team. Our client has specialised in pharmaceutical products and people's well-being for over a century and work with some well-known household brands. 


Responsibilities: 
  • Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
  • Supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
  • Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Prepares and compiles regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
  • EAME databases (RegPoint, HAQ) are fully maintained.

Requirements: 
  • Life sciences or chemistry graduate to honours level or equivalent.
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
  • Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc
  • Hybrid. 1 - 2 days in the office per week

If this role is of interest to you, please apply now!

 #LI-KT1
Save as a job alert
List #1

Similar Jobs

We are very sorry, but we cannot find the page you have requested (page not found).


Please use the links below to navigate the site and try to find what you're looking for.





    

  1. Life Sciences Jobs
    2. 


  2. Renewable Energy Jobs
    3. 


  3. Data Centres & IT Jobs
    4. 



Insights

QCS Staffing A Guide to Pharmacovigilance Careers

A Complete Guide to Pharmacovigilance Careers
Read more

05/15/2025

What is Pharmacovigilance (Drug Safety)?

What is Pharmacovigilance (Drug Safety)?
Read more

05/08/2024

stethoscope and colourful pills on a yellow background

5 reasons you should work in drug safety and pharmacovigilance
Read more

06/04/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV