
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 Specialist
Job Title. | Location | Salary | Actions |
Clinical Regulatory AssociateClinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permanent basis. As Clinical Regulatory Associate you will beaccountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. Responsibilities Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for which includes INDs, NDA, BLAs, NDSs, and oth...Location: Cork, |
Cork | Not Disclosed | |
Regulatory Affairs Technical Manager remote workingRegulatory Affairs Technical Manager 100% remote working Our client, an animal health organisation, are currently recruiting for a Regulatory Affairs Technical Manager to join their team. This is a super opportunity for an experienced Regulatory professional from an animal health or pharmaceutical background to work 100% remotely. Responsibilities Responsible for preparation of the Part 1 and CMC/Part 2 files for dossiers for Marketing authorisations Create and oversee studies needed, including technical/scientific input for pharmaceutical studies needed...Location: Kerry, |
Kerry | Not Disclosed | |
Clinical Publisher AssociateClinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide...Location: Cork, |
Cork | Not Disclosed | |
Regulatory Affairs SpecialistRegulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...Location: Cork, |
Cork | Not Disclosed | |
Senior Regulatory Affairs SpecialistSenior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...Location: Westmeath, |
Westmeath | 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.
Engineering Engineering Regulatory Affairs Manager Life Science Contract Senior Regulatory Affairs Officer Regulatory Affairs Officer Dublin Pharmaceutical Republic of Ireland Chemistry Clinical Research Regulatory Affairs Executive Galway Regulatory Affairs Quality Assurance Cork Regulatory Affairs Specialist Regulatory Affairs Clinical Research Kerry Contract Biopharmaceutical Regulatory Affairs Biotechnology Scientific Life Science Microbiology Medical Device
Group sites:
Quality Assurance Jobs |
Supply Chain Jobs |
Medical Device Jobs |
Engineering Jobs |
Pharmaceutical Jobs |
Chemistry Jobs |
Diagnostics Jobs |
Clinical Research Jobs |
Biopharmaceutical Jobs |
Biotechnology Jobs |
Contract Jobs |
Medical Affairs Jobs |
Science Jobs |
Connected Health Jobs |
Scientific Jobs |
Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy read our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 | Web Design / SEO by WebScience | Valid XHTML - CSS
Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy read our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 | Web Design / SEO by WebScience | Valid XHTML - CSS







