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
Search Results for Regulatory Affairs Consultant
Job Title. Location Salary Actions

Regulatory Affairs Specialist

Would you like to join a successful medical device compny in Ireland to further develop your career? This is an excellent opportunity to work with leading technologies in the medical device industry. The regulatory affairs specialist helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The regulatory affairs specialist serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities. Responsibilities Maint...

Location: Republic of Ireland,
Regulatory Affairs Specialist
Republic of Ireland Not Disclosed

Senior Associate Regulatory Affairs

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. This is an excellent position fo

Location: Dublin,
Senior Associate Regulatory Affairs
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Director of Regulatory Affairs Republic of Ireland Not Disclosed
Regulatory Affairs Specialist Dublin Not Disclosed
Director of Regulatory Affairs Republic of Ireland Not Disclosed
Director, Regulatory Affairs (Pediatrics/Infectious Diseases) Dublin Not Disclosed
Regulatory Affairs Specialist Dublin Not Disclosed
Director of Regulatory Affairs Republic of Ireland Not Disclosed
Director, Regulatory Affairs (Pediatrics/Infectious Diseases) Dublin Not Disclosed

Regulatory Affairs Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

  • Degree minimum in a relevant area.
  • Significant experience in Regulatory setting (CRO / Medical Device / Pharma / Biotech).
  • Team player and client-focussed.