
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.
![]() Google Chrome |
![]() Internet Explorer |
![]() Mozilla Firefox |
![]() 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 Executive
Job Title. | Location | Salary | Actions |
Reg Affairs SpecialistJob title: Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Responsibilities...Location: Clare, Galway, Galway City, Limerick, Limerick City, |
EU | Not Disclosed | |
Reg Affairs SpecialistJob title: Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Responsibilities...Location: Clare, Galway, Galway City, Limerick, Limerick City, |
EU | Not Disclosed | |
Reg Affairs SpecialistRole: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...Location: Connaught, Galway, Galway City, Leitrim, Limerick, |
EU | 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.
Group sites:
Diagnostics Jobs |
Contract Jobs |
Medical Device Jobs |
Medical Affairs Jobs |
Biopharmaceutical Jobs |
Engineering Jobs |
Scientific Jobs |
Biotechnology Jobs |
Science Jobs |
Supply Chain Jobs |
Chemistry Jobs |
Quality Assurance Jobs |
Connected Health Jobs |
Pharmaceutical Jobs |
Clinical Research Jobs |
Contract Jobs | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@contractjobs.ie
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS
Contract Jobs | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@contractjobs.ie
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS







