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

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs Specialist 		EU Not Disclosed
Subscribe RSS feed for this search

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.