I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Biostatistician
Dublin City Centre
API Purchaser
Dublin
Supply Chain Analyst
Dublin North
QA Manager
Dublin North
QA Manager
Dublin West
CTO
Galway
Administration Support
Dublin North
R&D Engineer
Galway
R&D Engineer
Dublin
Snr QA Specialist
Dublin South
Automation Technician
Dublin South
Risk Manager
Dublin
QA Manager Biologics
Dublin West
Consultant
Cork
Program Manager
Westmeath
QC Supervisor
Westmeath
QA Manager
Meath
Commodity Manager
Westmeath
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
Connect with me on
Close

Sign up for Regulatory Affairs Executive jobs email alerts

Email *


Frequency of Alert *

Daily Weekly Monthly
Search Results for Regulatory Affairs Executive
Job Title. Location Salary Actions

Regulatory Affairs Manager

Regulatory Affairs Manager Our client, a global pharmaceutical organisation are currently recruiting for a Regulatory Affairs Manager to join their team. Thi

Location: Dublin,
Regulatory Affairs Manager
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Specialist Galway Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Accreditation Manager Dublin Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Complaints Specialist contract x5 Galway Not Disclosed
Quality, Compliance and Regulatory Affairs Coordinator Dublin Not Disclosed

Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)

Responsibilities


  • Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
  • Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
  • Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
  • Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
  • Maintenance of approvals, including the preparation of annual reports for US products.
  • Assess and review documentation to ensure compliance with product licences.
  • Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
  • Actively participate in project teams, as required.

Qualifications / Experience

  • Minimum of 3 years regulatory experience in the pharmaceutical industry.
  • Knowledge of the current regulatory requirements, particularly US and EU.
  • Experience in writing and submitting regulatory documentation.