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QC Scientist
Limerick
Limerick
Data Scientist
Limerick
Limerick
Senior QC Specialist
Dublin
Dublin
Senior Tech Transfer Lead
Dublin
Dublin
Automation Engineer
Cork
Cork
R&D Technical Lead
Limerick
Limerick
Snr Associate QC
Dublin
Dublin
Qualified Person (QP)
Galway
Galway
Project Engineer
Dublin
Dublin
Process Engineer
Dublin North
Dublin North
Associate Director Quality Systems
Limerick
Limerick
Manufacturing Engineering Team Lead
Limerick
Limerick
Head of R&D
Galway
Galway
Quality Assurance Engineer
Dublin
Dublin
Associate Quality Engineer
Galway City
Galway City
Senior R&D Engineer
Galway
Galway
Principal Material Scientist
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Value Stream Manager
Dublin
Dublin
Medical Associate
Cork
Cork
QA Senior Associate
Dublin
Dublin
Quality Systems Manager
Galway
Galway
Mechanical Engineer
Dublin
Dublin
QA Senior Associate
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Senior Electronic Engineer
Limerick
Limerick
Project Engineer
Limerick
Limerick
Commissioning & Qualification Engine
Netherlands
Netherlands
Supply Chain Manager
Dublin
Dublin
Senior Associate QC
Dublin
Dublin
Sr Quality Engineer
Galway
Galway
QC Microbiology (Senior)
Dublin
Dublin
QC Associate Manager (LO A007956)
Limerick
Limerick
Injection Moulding Engineer
Limerick
Limerick
Engineering Shift Technician
Dublin South
Dublin South
S&OP Director
Cork
Cork
Principal Systems Engineer
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
Associate Director Warehouse & Logis
Limerick
Limerick
Process Engineer
Limerick
Limerick
Automation Engineer
Dublin
Dublin
Snr Associate QC
Dublin
Dublin
Quality Engineer
Cork
Cork
Senior R&D Engineer
Limerick City
Limerick City
Senior QA Specialist
Dublin
Dublin
Engineering Manager
Dublin
Dublin
Quality Engineer
Galway
Galway
Electro-Mechanical Shift Technician
Dublin North
Dublin North
Senior Business Development Manager (Nur
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Dublin
Dublin
Technician II
Galway
Galway
Regulatory Affairs Specialist
Limerick
Limerick
R&D Manager
Galway
Galway
Packaging Engineer
Galway
Galway
Senior Quality Engineer
Limerick
Limerick
Regulatory Affairs Specialist
Limerick
Limerick
Senior QC Microbiology
Dublin
Dublin
Quality Engineer II
Wexford
Wexford
Quality Engineer
Limerick
Limerick
Analytical Services Manager
Tipperary
Tipperary
Senior MES Engineer
Dublin
Dublin
Senior Technology Analyst
Limerick
Limerick
Project Engineer - Toolroom Set Up
Limerick
Limerick
Quality Engineer
Galway
Galway
Regulatory Project Manager
Dublin
Dublin
Snr Quality Engineer
Galway
Galway
Data Scientist
Limerick
Limerick
QC Manager
Dublin
Dublin
Validation Lead
Limerick
Limerick
QC Manager-chemistry (LOA007664 )
Limerick
Limerick
Principal Hardware Engineer
Galway
Galway
Product Engineer
Galway
Galway
Engineering Project Manager
Limerick
Limerick
Search Results for Regulatory Affairs Specialist
Job Title. | Location | Salary | Actions |
CMC Regulatory SpecialistCMC Regulatory Specialist Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. ...Location: Cork, |
Cork | Not Disclosed | |
CMC Regulatory AssociateCMC Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission rel...Location: Cork, |
Cork | Not Disclosed | |
CMC-Development Regulatory AssociateCMC – Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding stra...Location: Cork, |
Cork | Not Disclosed | |
Regulatory Affairs SpecialistRegulatory Affairs Specialist required for a Limerick based Medical Device facility. We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise. Compiles and communicates regulatory requirements...Location: Limerick, |
Limerick | Not Disclosed | |
Regulatory Affairs SpecialistRegulatory Affairs Specialist required for a Limerick based Medical Device facility. We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise. Compiles and communicates regulatory requirements %2...Location: Limerick, |
Limerick | Not Disclosed | |
Chief Technology Officer (CTO)Chief Technology Officer (CTO) Our client, a biotech organisation establishing operations in Ireland, are currently recruiting for a Chief Technology Officer to join their business. The main task of the CTO is to lead the device development part of the drug-device combination product. The CTO is involved in the strategy and operationalization of the technical development and regulatory strategy. Responsibilities Related to device development, coordinates input from external regulatory affairs consultants and identifies and closes knowledge gaps Lead device-related ac...Location: Dublin, |
Dublin | Not Disclosed | |
Regulatory Project ManagerRegulatory Project Manager Our client, a growing biotech organisation are currently recruiting for a Regulatory Project Manager to join their organisation on a permanent basis. As Regulatory Project Manager you will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. As Regulatory Project Manager you will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledg...Location: Dublin, |
Dublin | Not Disclosed | |
Quality and Regulatory Affairs ManagerQuality & Regulatory Affairs Manager Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction. Responsibilities Provide Quality & Regulatory ...Location: Dublin, |
Dublin | Not Disclosed |
Other Regulatory Affairs Jobs
Job Title | Location | Salary | Actions |
Senior Director, Regulatory Affairs (Biopharma) | Dublin | Not Disclosed | |
Senior Director, Regulatory Affairs (Biopharma) | Dublin | Not Disclosed | |
Senior Director, Regulatory Affairs (Biopharma) | Dublin | Not Disclosed | |
Senior Regulatory Affairs Specialist | Dublin | Not Disclosed | |
Associate Compliance Specialist - Manufacturing | Limerick | 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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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2020 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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