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Electronic Design Engineer
Galway
Galway
Analytical Chemist
Cork
Cork
Equipment Project Engineer
Limerick
Limerick
Maintenance Engineer
Cork
Cork
Quality Engineer
Galway
Galway
Assoc Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Process Team Lead
Donegal
Donegal
Quality Manager
Kerry
Kerry
Associate Scientist
Cork
Cork
Head of R&D
Galway
Galway
Maintenance Engineer
Dublin
Dublin
Quality Engineer
Limerick
Limerick
R&D Engineer
Limerick City
Limerick City
CAD Technician
Republic of Ireland
Republic of Ireland
Process Engineer
Limerick
Limerick
R&D Engineer
Galway
Galway
EHS Specialist
Cork
Cork
Quality Engineer
Limerick
Limerick
Maintenance Engineer
Cork
Cork
Process Team Lead
Donegal
Donegal
Senior Project Engineer
Dublin
Dublin
Quality Engineer - Validation
Limerick
Limerick
Senior Project Engineer
Limerick
Limerick
Senior CSV Specialist- Hybrid/Remote
Republic of Ireland
Republic of Ireland
Senior Scientist
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Project Engineer
Limerick
Limerick
Medical Affairs Indication Lead
Cork City
Cork City
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior Validation Engineer
Dublin
Dublin
Operations Manager
Galway
Galway
Strategic Automation Lead
Waterford
Waterford
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Engineering Technician
Dublin South
Dublin South
Senior R&D Engineer
Dublin
Dublin
C&Q Engineer
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Principal CAD Experience
Dublin
Dublin
Senior Project Manager
Limerick
Limerick
Principal Research Engineer
Galway City
Galway City
Process Engineer
Galway
Galway
VP Clinical Development
Republic of Ireland
Republic of Ireland
Program Manager
Galway
Galway
Quality Team Leader
Louth
Louth
CQV Lead
Tipperary
Tipperary
Project Engineer
Republic of Ireland
Republic of Ireland
Service Sales Representative
Dublin
Dublin
Operations Engineer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
R&D Senior Program Manager
Galway
Galway
Project Manager
Limerick
Limerick
Quality Engineer
Dublin
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
EHS Specialist
Cork
Cork
Manufacturing Engineer
Wexford
Wexford
Associate QC (Senior)
Dublin
Dublin
CSV Engineer
Limerick
Limerick
Project Engineer
Limerick
Limerick
Senior Project Manager
Dublin
Dublin
Lean Six Sigma Coach
Cork
Cork
Senior Technical Support ScientisT
Longford
Longford
Quality Systems Specialist
Limerick
Limerick
Quality Engineer
Dublin
Dublin
Project Engineer
Cork
Cork
Regulatory Affairs Specialist
Republic of Ireland
Republic of Ireland
Director, Clinical Development (Oncology
South East
South East
Process Team Lead
Donegal
Donegal
Bioprocess Associate
Dublin
Dublin
QA Specialist
Cork
Cork
Quality Systems Specialist
Galway
Galway
QC Bioassay Analyst
Cork
Cork
Maintenance CMMS Engineer
Tipperary
Tipperary
R&D Engineer
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Validation Engineer
Wicklow
Wicklow
Lean Expert
Cork
Cork
Product Planner
Dublin
Dublin
Senior R&D Engineer
Limerick City
Limerick City
Project Readiness Lead
Limerick
Limerick
QC Bioanalytical Analyst
Dublin
Dublin
Senior CSV Specialist- Hybrid
Republic of Ireland
Republic of Ireland
Project Engineer
Limerick
Limerick
Director of Quality Engineering
Limerick
Limerick
Senior Engineering Manager
Limerick
Limerick
Project Manager
Dublin
Dublin
R&D Manager
Galway
Galway
Manufacturing Engineer
Galway
Galway
Regulatory Affairs Director
Dublin
Dublin
Specialist Scheduler
Dublin
Dublin
EHS Specialist
Cork
Cork
Senior Quality Engineer
Galway
Galway
Equipment Project Engineer
Limerick
Limerick
Medical Device Director
Republic of Ireland
Republic of Ireland
Laboratory Technician
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Project Engineer
Tipperary
Tipperary
Senior Technical Writer
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
Senior Electronic Engineer
Limerick
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Manager
Dublin
Dublin
Manufacturing Engineer
Limerick
Limerick
Quality Engineer
Wexford
Wexford
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Equipment Project Engineer
Limerick
Limerick
Utilities Engineer
Dublin
Dublin
QC Leader
Cork
Cork
Senior R&D Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Controls Engineer
Dublin South
Dublin South
Senior R&D Clinical Engineer
Republic of Ireland
Republic of Ireland
CQV/Validation Engineer
Dublin
Dublin
Quality Engineer
Cork
Cork
Warehouse Manager
Louth
Louth
Principal Research Engineer
Galway
Galway
Senior Mechanical Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
QA Specialist
Meath
Meath
Manufacturing Specialist
Dublin South
Dublin South
Senior Quality Engineer
Limerick
Limerick
R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Materials Engineer
Cork
Cork
Senior Technical Writer
Dublin
Dublin
Senior QC Microbiology
Dublin
Dublin
Quality Specialist
Tipperary
Tipperary
Senior Validation Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Validation Engineer
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
Biostatistician
Cork
Cork
Process Engineer
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Process Engineer
Limerick
Limerick
Clinical Program Manager
Dublin
Dublin
MDR/Vigilance Specialist
Galway
Galway
Senior R&D Project Manager
Galway
Galway
Mechanical Engineer
Dublin
Dublin
Quality Assurance Specialist
Tipperary
Tipperary
Project Engineer
Limerick
Limerick
Senior Associate QC
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Process Engineer
Limerick
Limerick
Production Team Lead
Dublin South
Dublin South
Process Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Project Manager
Limerick
Limerick
Project Document Controller
Dublin
Dublin
GCP Inspector
Dublin
Dublin
Project Engineer
Limerick
Limerick
Senior Supply Chain Planner
Dublin
Dublin
Quality Engineer II
Galway
Galway
R&D Engineer
Galway
Galway
QC Team Leader
Cork
Cork
CMC Director
Dublin
Dublin
Search Results for Regulatory Affairs Specialist
Job Title. | Location | Salary | Actions |
Regulatory CMC AssociateRegulatory CMC Associate Our client, a global pharma company based in Cork, are currently recruiting for a Regulatory CMC Associate to join their team on a permanent basis with hybrid working. As Regulatory CMC Associate, together with the CMC Regulatory Affairs Scientist you will leads the various aspects of global marketing authorization submission management processes. You will assist in providing guidance on structure and content placement within CTD registration submissions and provide assistance with submission related Ministry of Health responses. Responsibili...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.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 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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