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
Close

Sign up for Regulatory Affairs Specialist jobs email alerts

Email *


Frequency of Alert *

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

Senior CMC Reg Affairs Specialist

Senior CMC Reg Affairs Specialist Our client is an organisation with a focus on the development and manufacture of generic pharmaceutical products. They are currently recruiting for a Senior CMC Reg Affairs Specialist to join their team based in Dublin. The successful candidate will report directly to the Head of Regulatory Affairs. The role will include some travel. Responsibilities • Critical review of high quality, Chemistry Manufacturing and Control (CMC) detailed regulatory documents and identify any possible deficiencies prior to dossier submission to EU and US A...

Location: Dublin,
Senior CMC Reg Affairs Specialist
Dublin Not Disclosed

Senior Regulatory Affairs Officer

Our client – a global pharmaceutical company – are seeking a Snr RA Officer for their Commercial base in west Dublin. Responsibilites: • Obta

Location: Dublin West,
Senior Regulatory Affairs Officer
Dublin West Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Director, Regulatory Affairs Dublin Not Disclosed
CMC Regulatory Affairs Director Dublin Not Disclosed
Senior Director, Regulatory Affairs Dublin Not Disclosed
Senior Director, Regulatory Affairs Dublin Not Disclosed

Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.

Salary Scale:


  • Regulatory Affairs Assistant - €25,000 - €28,000
  • Regulatory Affairs Officer - €32,000 - €39,000
  • Regulatory Affairs Specialist - €40,000 - €55,000
  • Regulatory Affairs Manager - €60,000 - €80,000
  • Regulatory Affairs Director - €85,000 +

Role 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 pharmaceutical 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.

Industry 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.