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LIMS Analyst
Cork
Cork
Process Engineer
Limerick
Limerick
Production Operator
Carlow
Carlow
R&D Director
Galway
Galway
Recruitment Consultant
Wexford
Wexford
Senior R&D Engineer
Galway
Galway
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Packaging Engineer
Dublin
Dublin
R&D Senior Program Manager
Galway
Galway
Quality Engineer
Athlone
Athlone
Principal R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Senior R&D Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Project Manager - R&D
Galway
Galway
Quality Manager
Clare
Clare
Quality Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
QC Bioassay Analyst (shift)
Carlow
Carlow
Quality Engineer
Athlone
Athlone
R&D Director
Galway
Galway
Quality Systems Enginer
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
Operations Lead
Dublin South
Dublin South
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Project Engineer
Clare
Clare
EHS Systems Specialist
Carlow
Carlow
Senior QC Associate
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Quality Technician
Carlow
Carlow
Sourcing Specialist
Tipperary
Tipperary
Facilities Engineer
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Strategic Automation Lead
Waterford
Waterford
Maintenance Planner
Carlow
Carlow
Product Development Engineer
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
QC Lab Technician
Carlow
Carlow
Manufacturing Engineer
Wexford
Wexford
Quality Validation Engineer
Limerick
Limerick
EHS Systems Specialist
Dublin
Dublin
Clean Utilities Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Associate Quality Control
Dublin South
Dublin South
Biomedical Engineer
Dublin
Dublin
Aseptic Process Owner Lead
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Validation Engineer
Cork
Cork
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Manufacturing Shift Lead
Donegal
Donegal
Regulatory Affairs Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Process Engineer
Cork
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Electronic Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
CQV Lead
Tipperary
Tipperary
Senior R&D Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Specialist Operations Engineer
Tipperary
Tipperary
Manufacturing Technician
Clare
Clare
Senior R&D Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
Engineering Manager
Clare
Clare
Pharmaceutical Operator
Louth
Louth
R&D Chemist
Cork
Cork
Quality Control Technician
Carlow
Carlow
Director of Quality Engineering
Limerick
Limerick
E&I Turnover Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Principal R&D Engineer
Galway
Galway
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Engineering Projects Lead
Carlow
Carlow
Senior Operations Engineer
Galway
Galway
QC Chemistry Analyst (Shift)
Carlow
Carlow
Clinical Project Manager
Dublin
Dublin
Quality Manager
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior QC 24/7 Shift
Dublin
Dublin
Product Development Engineer
Galway
Galway
Project Engineer
Republic of Ireland
Republic of Ireland
R&D Manager
Galway
Galway
Quality Manager
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Electronic Engineer
Dublin
Dublin
Operations Specialist
Louth
Louth
Quality Technician
Dublin
Dublin
Quality Systems Manager
Dublin
Dublin
R&D Program Manager - Senior
Galway
Galway
Qualified Person
Limerick
Limerick
EHS Specialist
Carlow
Carlow
Engineering Business Manager
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Limerick
Limerick
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Process Engineer
Galway
Galway
Project Engineer
Tipperary
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Project Process Engineer
Carlow
Carlow
Senior Quality Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Mechanical Design Engineer
Germany
Germany
Suite Team Delivery Lead
Tipperary
Tipperary
Senior Electronics Engineer
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Head of R&D
Galway
Galway
Product Development Engineer
Dublin
Dublin
QA Engineer
Leitrim
Leitrim
QC Bioanalytical Analyst
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Technical Writer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Senior QA Associate
Cork
Cork
Aseptic Process Lead
Carlow
Carlow
Chemical Engineer
Tipperary
Tipperary
Quality Technician
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Quality Systems Specialist
Carlow
Carlow
Quality Technician
Dublin
Dublin
Production Operator
Carlow
Carlow
Maintenance Engineer
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
Engineering Specialist - Greece
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Project Engineer
Limerick
Limerick
QC Analyst
Meath
Meath
Validation Lead
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Clean Utilities Engineer
Carlow
Carlow
Supply Chain Planner
Waterford
Waterford
Senior QC Associate
Dublin
Dublin
Quality Systems Specialist
Galway
Galway
Project Manager - Suite Lead
Tipperary
Tipperary
Validation Engineer
Carlow
Carlow
Senior Mechanical Engineer
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
Project Enginer
Dublin South
Dublin South
Associate Quality Specialist
Tipperary
Tipperary
Quality Specialist
Tipperary
Tipperary
Senior Quality Engineer
Limerick
Limerick
Manufacturing Engineer
Limerick
Limerick
Senior Electronic Engineer
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Senior HVAC Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Project Manager
Limerick
Limerick
Principal Process Equipment Engineer
Dublin South
Dublin South
QC Laboratory Technician
Carlow
Carlow
Production Operator
Carlow
Carlow
Change Control Coordinator
Carlow
Carlow
Senior Regulatory Affairs
Galway
Galway
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Electrical Engineer
Limerick
Limerick
Process Engineer (Shift)
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
EHS Project Lead
Cavan
Cavan
Automation Engineer
Cavan
Cavan
Maintenance Engineer
Cork
Cork
Quality Manager - NPI
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Senior Electrical Engineer
Galway
Galway
Process Development Engineer
Galway
Galway
Quality Control Technician
Carlow
Carlow
Senior Design Engineer
Dublin
Dublin
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Biostatistician
Dublin City Centre
Dublin City Centre
Microbiology Technician
Dublin
Dublin
Quality Engineer
Wexford
Wexford
Senior R&D Engineer
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Product Development Engineer
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
QA Specialist
Cork
Cork
Senior Quality Engineer
Leitrim
Leitrim
Quality Technician
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Principal R&D Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Associate Global Trade Ops
Dublin
Dublin
Project Engineer
Roscommon
Roscommon
Senior Quality Engineer
Dublin
Dublin
Project Engineer
Westmeath
Westmeath
Medical Device Director
Republic of Ireland
Republic of Ireland
Engineering Lead - Greece
Republic of Ireland
Republic of Ireland
Process Support Specialist
Carlow
Carlow
Senior Validation Engineer
Dublin
Dublin
C&Q Lead
Tipperary
Tipperary
R&D Engineer
Dublin
Dublin
Senior R&D Manager/Director
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Electrical Engineer
Cork
Cork
Senior Quality Engineer
Dublin
Dublin
Senior Technical Writer
Dublin
Dublin
Program Manager
Cork
Cork
R&D Director
Galway
Galway
Injection Moulding Engineer
Leitrim
Leitrim
Search Results for Regulatory Affairs Specialist
Job Title. | Location | Salary | Actions |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 the Se...Location: Athlone, Clare, Connaught, Galway, Galway City, |
EU | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist 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 the Senior Reg...Location: Athlone, Clare, Connaught, Galway, Galway City, |
EU | Not Disclosed | |
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 | |
CMC Pre-Approval Regulatory ScientistCMC Pre-Approval Regulatory Scientist Our client, a global pharma company, are currently recruiting for a CMC Pre-Approval Regulatory Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts.. As CMC Pre-Approval Regulatory Scientist, you will partner with Global Regulatory Affairs – CMC (GRA-CMC) Regulatory Scientists to provide strategic, tactical and operational direction and support to expedite CMC development of the organisations portfolio by developing successful regul...Location: Cork, |
Cork | Not Disclosed | |
Principal Scientist Global Regulatory Affairs CMCPrincipal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and are currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC to join their team on a permanent basis. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration...Location: Limerick, |
Limerick | Not Disclosed | |
Regulatory Affairs ManagerRegulatory Affairs Manager Our client, a pharma organisation, are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis with hybrid working. Experience working with oral solid dosage (OSD) forms is essential for this role. You will work with a small team in Ireland and other team members across the UK and EU. Responsibilities Advise and liaise services on behalf of company to ensure that requirements of national competent authorities are met Create, assemble, review and publish regulatory submissions in accordance with agreed ...Location: Dublin, |
Dublin | Not Disclosed | |
CMC Regulatory Principal ScientistCMC Regulatory Principal Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration...Location: Cork, |
Cork | Not Disclosed | |
CMC Regulatory Senior ScientistCMC Regulatory Senior Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissi...Location: Cork, |
Cork | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob 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. Rep...Location: Athlone, Clare, Connaught, Galway, Galway City, |
EU | Not Disclosed | |
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 | |
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
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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