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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 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.
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Pharmaceutical | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@pharmaceutical.ie | Copyright © 2012 Life Science Recruitment Ltd
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Pharmaceutical | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@pharmaceutical.ie | Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS







