I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Hot Science Jobs
R&D Director
Galway
Quality and Regulatroy Manager
Galway
Clean Utilities Engineer
Carlow
R&D Manager
Galway
Project Manager
Galway
QA Manager
Canada
Senior Project Engineer - Utilities
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Quality Engineer
Dublin
E&I Turnover Engineer
Carlow
Manufacturing Engineer
Cork
Senior Process Engineer
Cork
Lead Maintenance Reliability Engineer
Westmeath
Clinical Monitor
Dublin
Senior Associate Quality Control
Dublin
Product Development Engineer
Dublin
Technical Transfer Specialist
Cork
Senior Polymer Development Engineer
Galway
Program Manager
Cork
Senior Validation Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Injection Moulding Engineer
Leitrim
Project Engineer
Republic of Ireland
Senior Validation Engineer
Limerick
C&Q Lead
Tipperary
Senior Manager Device Supplier Assurance
Dublin
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
Project Engineer
Tipperary
Manufacturing Biotech Associate 24/7 Shi
Meath
R&D Engineer
Galway
Principal Engineer
Dublin
E&I Turnover Engineer
Carlow
R&D Engineer
Clare
Quality Control Technician
Carlow
Clean Utilities Engineer
Cork
R&D Engineer
Galway
Senior Technical Transfer Specialist
Cork
Technical Specialist - Manufacturing Pro
Cork
Product Lead
Dublin
Commissioning and Qualification Engineer
Dublin
Applications Scientist
Dublin
Project Process Engineer
Carlow
(Senior) Manufacturing Engineers - Globa
Limerick
Chemical Engineer
Tipperary
Senior E&I Maintenance Technician
Carlow
R&D Manager
Galway
Process Development Engineer
Galway
Process Engineer (Shift)
Carlow
QA Manager
Canada
Senior Equipment Design Engineer
Dublin
R&D Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Engineer
Galway
Manufacturing Engineer
Galway
Senior Manufacturing Engineer
Cork
Clinical Trial Quality Representative
Cork
Process Support Specialist
Carlow
Injection Molding Engineer
North Leinster
Process Simulation Technical Engineer
Carlow
Clean Utilities Engineer
Carlow
Principal Engineer
Dublin
Senior Associate Quality Control NPI
Dublin
Technical Specialist - Manufacturing Pro
Cork
Mechanical Design Engineer
Germany
Senior Product Development Engineer
Galway
Project Engineer
Limerick
Senior Quality Engineer
Dublin
Downstream Manufacturing Engineer
Dublin
Strategic Automation Lead
Waterford
R&D Manager
Galway
Manufacturing Project Engineer
Sligo
Senior Manufacting Engineer
Republic of Ireland
Production Operator
Carlow
Product Development Engineer
Galway
Production Operator
Dublin
Cleaning Validation Specialist
Cork
R&D Director
Galway
Quality Validation Engineer
Limerick
Senior Recruitment Consultant
Republic of Ireland
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Maintenance Engineer
Carlow
QC External Sample and Retain Coordinato
Carlow
Advanced Technologies R&D Manager
Clare
R&D Senior Program Manager
Galway
Advanced Technologies R&D Manager
Clare
Senior Regulatory Affairs Specialist
Athlone
Principal R&D Engineer
Dublin
Senior R&D Engineer
Dublin
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Senior Process Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
NPI Process Engineer
Carlow
Validation Engineer
Carlow
R&D Program Manager
Dublin
Senior Design Assurance Engineer
Galway
Product Development Engineer
Galway
Regulatory Affairs Specialist
Cork
Buyer
Wexford
Senior Process Engineer
Cork
Senior Regulatory Affairs Specialist
Athlone
Senoior Specialist - MS&T
Dublin
Chief Medical Officer
Dublin
Injection Moulding Engineer
Athlone
Master Data Associate
Limerick
Quality Manager - NPI
Dublin
Account Manager UK and Ireland
Republic of Ireland
Principal Device Engineer
Dublin
Change Control SME
Cork
Senior Director Statistics Data and Anal
Cork
QC Separation Analyst
Cork
Clinical Research Program Manager
Galway
Quality Specialist
Clare
Product Development Manager
Galway
EHS Systems Specialist
Dublin
R&D Manager
Connaught
Validation & Verification Engineer
Dublin
Quality Specialist - Remediation
Louth
Principal Scientist Device and Product P
Dublin
CQV Lead
Tipperary
Senior Microbiology Specialist - Greece
Republic of Ireland
Senior Microbiologist
Republic of Ireland
Project Manager
Galway
Process Engineer
Limerick
Senior QC Associate
Dublin
R&D Manager
Connaught
Senior Design Engineer
Dublin
R&D Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Senior Recruitment Consultant
Dublin
R&D Manager
Connaught
Senior Operations Engineer
Galway
Senior Quality Engineer
Galway
Senior Validation Engineer
Limerick
Software Design Assurance Engineer
Dublin
Production Operator
Carlow
Principal Process Equipment Engineer
Dublin South
Maintenance CMMS Engineer
Tipperary
VP of Operations
Dublin
Technical Specialist - Process Support
Cork
Senior HVAC Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Principal Software Engineer
Athlone
Maintenance Technician
Carlow
R&D Manager
Connaught
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Clare
MS&T Bioprocess Engineer
Meath
Cleaning Validation Specialist
Cork
Project Manager - R&D
Galway
Maintenance Engineer
Cork
Maintenance Reliability Engineer
Cork
Technical Sales Manager (Chemistry)
Westmeath
Process Chemist
Limerick
Senior QC Microbiology (24/7 Shift)
Dublin
R&D Manager
Dublin
Manufacturing Technician
Clare
R&D Project Manager
Galway
R&D Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Quality Manager
Dublin
Senior QC 24/7 Shift
Dublin
QA Engineer
Leitrim
Technical Administrator
Tipperary
R&D Engineer
Galway
Regional Program Coordinator - Global Le
Dublin
Senior R&D Engineer
Dublin
Senior Design Quality Engineer
Dublin
Senior QC Associate
Dublin
Senior R&D Manager
Athlone
Product Development Engineer II
Athlone
Director of Quality Engineering
Limerick
Senior Quality Engineer
Limerick
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Process Development Engineer
Galway
Technical Transfer Specialist
Cork
Cleaning Validation Specialist
Cork
Senior Human Factors Engineer
Dublin
Technical Transfer Lead
Dublin
Quality Specialist
Tipperary
Validation Engineer
Cork
Cleaning Validation Engineer
Carlow
Manufacturing Technician
Clare
Process Validation Engineer
Cork
Advanced Technologies Manager
Galway
Senior Electrical Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Chief Medical Officer
Dublin
Biostatistician
Dublin City Centre
Process Engineer (NPI)
Carlow
Senior Regulatory Affairs Specialist
Clare
Project Enginer
Dublin South
Project Engineer
Roscommon
Project/Process Engineer - Purification
Cork
Engineering Business Manager
Dublin
Maintenance Reliability Engineer
Tipperary
Project Engineer
Cork
Lead Project Engineer
Carlow
Associate Director Global Regulatory Aff
Cork
Senior Electronic Engineer
Dublin
Project Manager - R&D
Galway
Cleaning Validation Specialist
Carlow
Senior Electronic Engineer
Dublin
Project Manager
Limerick
Quality Specialist
Tipperary
Senior Technical Transfer Engineer
Cork
Responsible Person (RP)
Republic of Ireland
R&D Engineer
Galway
R&D Engineer
Galway
Change Control Coordinator
Carlow
Technical Transfer Specialist
Dublin
Sr. Associate - Quality for Computer Sys
Cork
Product Development Manager
Galway
Clinical Affairs Specialist
Galway
Scientist (hybrid)
Meath
QC Laboratory Technician (shift)
Carlow
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Galway
Senior Microbiologist
Dublin
Quality Systems Manager
Dublin
Validation Specialist - 50/50 remote
Carlow
Injection Molding Engineer
North Leinster
Project Manager - Capital Projects
Cork
Senior Technical Scientist - Technical T
Cork
Lead Maintenance Reliability Engineer
Westmeath
Senior R&D Engineer
Galway
R&D Manager
Athlone
Recruitment Consultant
Republic of Ireland
Manufacturing Technician
Clare
Validation Engineer
Athlone
Principal Quality Engineer
Galway
R&D Manager
Athlone
R&D Manager
Galway
Reliability Engineering Specialist
Louth
R&D Engineer
Dublin
Senior Mechanical Engineer
Dublin
Senior Recruitment Consultant
Cork
Head of R&D
Galway
Materials Management Scientist
Limerick
Clinical Project Manager
Cork
Quality Engineer
Galway
Consultant




Search Results for Regulatory Affairs Specialist
Job Title. Location Salary Actions

Principal Scientist Global Regulatory Affairs CMC

Principal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently recruting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site. This is a permanent role withhybrid working. 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 submissions, and post-approval submissions. Resp...

Location: Cork,
Principal Scientist Global Regulatory Affairs CMC 		Cork Not Disclosed

Associate Director Global Regulatory Affairs

Associate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a diverse and highly capable workforce Ensure robust individual training plans and timely completion of required training for direct reports Support and enable talent identification and career development that refl...

Location: Cork,
Associate Director Global Regulatory Affairs 		Cork Not Disclosed

Senior Regulatory Affairs Specialist

Job 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,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job 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,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job 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,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job 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,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job 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,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Reg Affairs Specialist - Post Market

Job 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,
Senior Reg Affairs Specialist - Post Market 		Galway Not Disclosed

Senior Regulatory Affairs Specialist

Job 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,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Regulatory Affairs Specialist

Regulatory 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,
Regulatory Affairs Specialist 		Cork Not Disclosed

Senior Regulatory Affairs Specialist

Senior 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,
Senior Regulatory Affairs Specialist 		Westmeath Not Disclosed
Subscribe RSS feed for this search

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.