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Quality Manager
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Senior Validation Engineer
Dublin
Dublin
Maintenance Engineer
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Validation Engineer
Cork
Cork
Senior Operations Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Quality Systems Specialist
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
Senior QC Associate
Dublin
Dublin
Quality Technician
Dublin
Dublin
Senior Operations Manager
Tipperary
Tipperary
R&D Director
Galway
Galway
EHS Systems Specialist
Dublin
Dublin
Quality Engineer
Galway
Galway
Aseptic Process Lead
Carlow
Carlow
Senior Engineering Manager
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Program Manager
Cork
Cork
Senior Electronic Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Suite Team Delivery Lead
Tipperary
Tipperary
Digital Lab Records Specialist
Tipperary
Tipperary
Clean Utilities Engineer
Carlow
Carlow
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Quality Validation Engineer
Limerick
Limerick
Facilities Engineer
Carlow
Carlow
Engineering Manager
Clare
Clare
Senior Project Manager - Process Develop
Dublin South
Dublin South
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior R&D Engineer
Galway
Galway
QC Chemistry Analyst (Shift)
Carlow
Carlow
Senior R&D Engineer
Clare
Clare
QC Analyst
Meath
Meath
Laboratory & Quality Manager
Dublin
Dublin
Quality Engineer
Galway
Galway
QC Bioanalytical Analyst
Dublin
Dublin
Senior R&D Manager/Director
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Senior Mechanical Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
Associate Global Trade Ops
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Clinical Affairs Manager
Galway
Galway
C&Q Lead
Tipperary
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Project Manager - Suite Lead
Tipperary
Tipperary
Clean Utilities Engineer
Carlow
Carlow
Aseptic Process Owner Lead
Dublin
Dublin
R&D Manager
Galway
Galway
Quality Technician
Carlow
Carlow
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Limerick
Limerick
Packaging Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Chemical Engineer
Tipperary
Tipperary
EHS Systems Specialist
Carlow
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
QA Associate Specialist
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Principal Process Equipment Engineer
Dublin South
Dublin South
Quality Manager - NPI
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Distribution Centre Manager
Dublin
Dublin
Electrical Engineer
Cork
Cork
Senior HVAC Engineer
Dublin
Dublin
Quality Engineer
Wexford
Wexford
Associate Quality Specialist
Tipperary
Tipperary
Senior Validation Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Trainer
Dublin
Dublin
R&D Manager
Galway
Galway
Director of Quality Engineering
Limerick
Limerick
R&D Program Manager
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Project Engineer
Clare
Clare
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
R&D Director
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
EHS Project Lead
Cavan
Cavan
R&D Director
Galway
Galway
Change Control Coordinator
Carlow
Carlow
Project Manager - R&D
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Electrical Engineer
Limerick
Limerick
Validation Engineer
Carlow
Carlow
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Associate Quality Specialist
Tipperary
Tipperary
Senior Validation Engineer
Limerick
Limerick
Senior R&D Engineer
Clare
Clare
Head of R&D
Galway
Galway
Senior R&D Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
Project Manager
Limerick
Limerick
Process Engineer
Cork
Cork
Senior R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Quality Technician
Dublin
Dublin
Process Development Engineer
Galway
Galway
Senior QC 24/7 Shift
Dublin
Dublin
R&D Manager
Galway
Galway
Production Operator
Carlow
Carlow
Project Engineer
Limerick
Limerick
QC Chemistry Analyst
Carlow
Carlow
Qualified Person
Limerick
Limerick
Recruitment Consultant
Wexford
Wexford
Senior Quality Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Design Assurance Engineer
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
Project Engineer
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Quality Specialist (hybrid)
Tipperary
Tipperary
Product Development Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
Process Engineer
Galway
Galway
R&D Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior Technical Writer
Dublin
Dublin
Project Engineer
Tipperary
Tipperary
Automation Engineer
Cavan
Cavan
Senior EHS Specialist
Louth
Louth
Pharmaceutical Operator
Louth
Louth
Operations Specialist
Louth
Louth
Senior Process Enginer
Dublin South
Dublin South
Senior Associate Quality Operations
Limerick
Limerick
Quality Systems Enginer
Dublin
Dublin
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Quality Systems Specialist
Galway
Galway
Manufacturing Engineer
Galway
Galway
Specialist Operations Engineer
Tipperary
Tipperary
Principal R&D Engineer
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
CQV Lead
Tipperary
Tipperary
Maintenance Planner
Carlow
Carlow
Engineering Business Manager
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Manufacturing Shift Lead
Donegal
Donegal
Electronic Design Engineer
Galway
Galway
E&I Turnover Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Sourcing Specialist
Tipperary
Tipperary
Maintenance Engineer
Cork
Cork
Quality Specialist
Tipperary
Tipperary
Quality Manager
Clare
Clare
Senior Associate Quality Control
Dublin South
Dublin South
Manufacturing Engineer
Wexford
Wexford
Process Support Specialist
Carlow
Carlow
R&D Director
Galway
Galway
QC Bioassay Analyst (shift)
Carlow
Carlow
R&D Senior Program Manager
Galway
Galway
Quality Manager
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Strategic Automation Lead
Waterford
Waterford
Quality Manager - NPI
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Project Manager
Louth
Louth
Product Development Engineer
Galway
Galway
Quality Systems Manager
Dublin
Dublin
Graduate R&D Engineer
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Process Engineer
Limerick
Limerick
QC Laboratory Technician
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
E&I Turnover Engineer
Carlow
Carlow
Process Engineer (Shift)
Carlow
Carlow
Manufacturing Engineer
Limerick
Limerick
Process Support Specialist
Carlow
Carlow
Embedded Software Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Project Process Engineer
Carlow
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Search Results for Regulatory Affairs Executive
Job Title. | Location | Salary | Actions |
Associate / Sr Associate (Regulatory Labelling)Associate / Sr Associate - Regulatory Labelling Our client is a global healthcare leader. Their employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. They are looking for people who are determined to make life better for people around the world. For more than 140 years, they have worked tirelessly to discover medicines that make life better. They are currently seeking a Labelling Associate / Senior Labeling...Location: Cork, |
Cork | Not Disclosed | |
Senior Reg Affairs Specialist - Post MarketJob title: Senior Regulatory Affairs Specialist – Post market 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. Reporting to t...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...Location: Clare, Connaught, Galway, Galway City, Limerick, |
EU | 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 |
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.
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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.
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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
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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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
Valid XHTML - CSS