Browse by job sector

EMEA Regulatory Affairs

  1. East Anglia
Buckingham
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
34584
Apply to this job Save job
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
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Global Regulatory & Operations Lead

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Contract

Location

Dublin

Description

Global Regulatory & Operations Lead - Operations Lead - Ireland/Dublin Our client is a global supplier of sterile Injectable pharmaceutical products. They currently market and distribute a

Reference

34847

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more
Senior Manager Regulatory Affairs

Salary

Competitive

Location

Central London

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Contract

Location

London

Description

Senior Manager Regulatory Affairs - Remote, UK - 12-Months  Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Manager Regulatory Affairs. A

Reference

34339

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more
Regulatory Affairs Manager

Salary

Competitive

Location

Uxbridge

Salary

Competitive

Sector

Drug Safety / Pharmacovigilance

Job type

Contract

Location

London

Description

Regulatory Affairs Manager - Uxbridge - 12-Month Contract    Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Regulatory Affairs Manager. A leader

Reference

35130

Expiry Date

01/01/0001

Kathryn Taylor

Author

Kathryn Taylor
Kathryn Taylor

Author

Kathryn Taylor
Read more
Read more

Insights

What is Pharmacovigilance (Drug Safety)?

What is Pharmacovigilance (Drug Safety)?
Read more

05/08/2024

Picture of a pill with safety written on it

How has pharmacovigilance changed since the COVID-19 pandemic?
Read more

06/29/2022

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