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
CQV Engineer (CIP Start Up)
Denmark
Principal R&D Engineer
Dublin
Process Chemist
Limerick
Recruitment Consultant
Republic of Ireland
Senior Regulatory Affairs Specialist
Athlone
Technical Transfer Specialist
Dublin
Senior Project Engineer
Cavan
Project Manager - R&D
Galway
Packaging Engineer
Dublin
Advanced Technologies Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
Recruitment Consultant
Wexford
R&D Engineer
Dublin
QC Laboratory Technician
Carlow
QC Separation Analyst
Cork
Project Engineer
Limerick
Principal Software Engineer
Athlone
Account Manager UK and Ireland
Republic of Ireland
Product Development Engineer
Dublin
R&D Technician II
Galway
Technical Specialist - Process Support
Cork
R&D Director
Galway
Validation Engineer
Athlone
Project Manager
Limerick
Senior R&D Manager
Athlone
Senior Quality Engineer-Remote
Republic of Ireland
E&I Turnover Engineer
Carlow
Manufacturing Engineer
Limerick
Senior Research and Development Engineer
Galway
Quality Assurance Operations (Hybrid)
Meath
Senior R&D Engineer
Dublin
Clinical Research Physician (CRP) and He
Cork
Senior Operations Engineer
Galway
R&D Senior Program Manager
Galway
Senior Validation Engineer
Limerick
Biomedical Engineer
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Associate Supply Chain Import/Export Spe
Dublin
Technical Transfer Engineer - Drug Subst
Louth
Associate QA Specialist (Shift)
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Clean Utilities Engineer
Carlow
Production Operator
Carlow
R&D Project Manager
Galway
Product Development Engineer
Galway
Process Engineer (NPI)
Carlow
Master Data Associate
Limerick
Supply Chain Import / Export Specialist
Dublin
Senior Project Engineer
Cavan
Project Engineer
Roscommon
Biomedical Engineer
Dublin
Quality Specialist
Clare
Clean Utilities Engineer
Carlow
Quality Control Technician
Carlow
Chemical Engineer
Tipperary
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Quality Technician
Dublin
Senior Electrical Project Engineer
Dublin
Technical Quality Assurance Specialist
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Process Development Engineer
Galway
Microbiology Technician
Carlow
Manufacturing Technician
Clare
Associate Director Global Regulatory Aff
Cork
Commissioning, Qualification and Valid
Carlow
Quality Specialist & Deputy RP
Limerick
Manager R&D
Connaught
Senior Project Manager - Process Develop
Dublin
Principal Preclinical Scientist
Galway
Principal/Senior R&D Engineer Cathet
Galway
Manufacturing Engineer
Cork
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Shift Technician (Injection Moulding)
Kildare
Senior R&D Engineer
Dublin
Product Development Engineer
Galway
Cleaning Validation Specialist
Cork
Software Design Assurance Engineer
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior QC Associate
Dublin
Cleaning Validation Specialist
Cork
Remote Process Engineer - Fill Finish
Republic of Ireland
E&I Turnover Engineer
Carlow
Head of R&D
Galway
Senior Human Factors Engineer
Dublin
R&D Manager
Galway
Clinical Trial Quality Representative
Cork
QA Manager
Canada
Senior Electronic Design Engineer
Dublin
Manufacturing Engineer
Galway
CSV Engineer - IT Labs
Limerick
Senior Recruitment Consultant
Republic of Ireland
Applications Scientist
Dublin
Cleaning Validation Specialist
Carlow
Project Manager - R&D
Galway
Principal Device Engineer
Dublin
Senior Validation Engineer
Dublin
Senior Quality Control Associate
Dublin South
Technical Marketing Manager
Wexford
Senior R&D Engineer
Galway
Commisioning and Qualification Engineer
Cork
Quality Technician
Dublin
Project Engineer
Clare
Maintenance Engineer
Cork
Purchasing Specialist
Waterford
Lead Project Engineer
Carlow
Senior Validation Engineer
Cork
Quality and Regulatroy Manager
Galway
Senior Utility Project Engineer
Dublin
Embedded Software Engineer
Dublin
Senior R&D Engineer
Clare
Senior Quality Engineer
Dublin
Product Development Engineer
Galway
C&Q Lead
Tipperary
Senior Manufacting Engineer
Republic of Ireland
QA Manager
Canada
R&D Engineer
Dublin
Senior R&D Manager
Athlone
R&D Manager
Connaught
NPI Process Engineer
Carlow
Quality Assurance Engineer
Longford
Technical Specialist - Manufacturing Pro
Cork
QC Bioassay Analyst
Carlow
R&D Manager
Connaught
Senior Design Quality Engineer
Dublin
Scientist (hybrid)
Meath
Technical Specialist - Analytical &
Cork
Senior Project Equipment Engineer
Dublin
Process Engineer
Limerick
Senior Process Engineer
Cork
Project Enginer
Dublin South
Supply Chain Process Lead
Louth
Senior R&D Engineer
Galway
Biostatistician
Dublin City Centre
QA Specialist - Validation and NPI
Carlow
Technical Writer
Dublin
Microbiologist
Louth
Senior Recruitment Consultant
Dublin
CQV Lead
Tipperary
Associate Director Clinical Development
Cork
Chief Medical Officer
Dublin
Manufacturing Project Engineer
Sligo
Advanced Technologies R&D Manager
Clare
Lead Maintenance Reliability Engineer
Westmeath
Clinical Research Program Manager
Galway
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior Project Engineer
Cork
R&D Director
Galway
Validation Engineer
Limerick
R&D Manager
Connaught
Senior R&D Engineer
Galway
Senior Process Development Engineer
Galway
Product Lead
Dublin
Quality Engineer
Galway
QC Analyst - Analytical Testing
Meath
Senior Regulatory Affairs Specialist
Athlone
Operations Specialist
Louth
R&D Engineer
Galway
R&D Manager
Connaught
R&D Manager
Galway
VP of Operations
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Project Engineer
Tipperary
Principal Process Development Engineer
Galway
Product Development Engineer II
Athlone
QA Supplier Specialist
Carlow
Director of Quality Engineering
Limerick
Project Process Engineer
Carlow
R&D Engineer
Clare
Senior Quality Engineer
Leitrim
Production Operator
Carlow
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Injection Moulding Engineer
Leitrim
Senior Equipment Design Engineer
Dublin
Senior Operations Engineer
Galway
Injection Moulding Engineer
Athlone
Lead Maintenance Reliability Engineer
Westmeath
Quality Specialist
Tipperary
Change Control Lead
Tipperary
Principal Engineer
Dublin
Quality - Tech Transfer Specialist
Cork
R&D Engineer
Galway
Instrument Specialist
Tipperary
Senior R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
Operational Excellence Specialist
Meath
Process Microbiologist
Cork
R&D Technical Life Cycle & Engin
Galway
Quality Engineer
Athlone
R&D Manager
Athlone
Product Development Technician II
Galway
Senior Project Engineer - Utilities
Dublin
CQV Engineer - SIP Start Up
Denmark
R&D Director
Galway
R&D Engineer
Galway
Suite Team Delivery Lead
Tipperary
Senior Maintenance Technician
Carlow
Senior R&D Engineer
Dublin
Technical Transfer Specialist
Cork
Project Engineer
Republic of Ireland
R&D Engineer
Clare
Responsible Person (RP)
Republic of Ireland
Quality Auditor (Systems Specialist)
Tipperary
Quality Engineer
Athlone
Facilities Engineer
Carlow
Senior Quality Assurance Specialist
Dublin
Senior Director Statistics Data and Anal
Cork
Staff R&D Engineer- Customer Focus
Dublin
Senior Operations Engineer
Galway
Principal Heart Valves Engineer
Galway
Process Support Specialist
Carlow
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Injection Moulding Engineer
Athlone
R&D Technician
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Project Manager
Galway
Manufacturing Technician
Clare
Validation Engineer
Cork
Process Engineer - Water Formulations
Limerick
Process Support Specialist
Carlow
Quality Manager / PRRC
Dublin
QA Engineer
Leitrim
Senior Equipment Engineer
Dublin
Senior Validation Engineer
Limerick
Consultant




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

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

Associate Director Clinical Regulatory Scientist

Associate Director Clinical Regulatory Scientist(Specialising in Paediatrics) Our client, a global pharma company are currently recruiting for an Associate Director Clinical Regulatory Scientist (Specialising in Paediatrics) to join their team and a permanent basis. As Associate Director Clinical Regulatory Scientist you will develop and execute the regulatory strategy for the US and Canadian markets. This role offers hybrid working. Responsibilities Develop, Update and Execute US and Canada Registration Strategy Initiate and Update Regulatory Strategy Doc...

Location: Cork,
Associate Director Clinical Regulatory Scientist 		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.