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.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished

Sign up for Regulatory Affairs Specialist jobs email alerts

Email *

Frequency of Alert *

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

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager
Dublin North Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client, a global pharmaceutical organisation are currently recruiting for a Regulatory Affairs Manager to join their team. Thi

Location: Dublin,
Regulatory Affairs Manager
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Officer Limerick €45000 - €50000

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.
BD Manager Westmeath QA Specialist Contract Scientist Qualified Person Dublin QA Analyst Chemist Engineering Engineering Manager Pharmacist Project Manager Supply Chain Biotechnician Nurse Associate Validation Coordinator Biomedical Engineer Quality Manager Republic of Ireland Formulation Chemist Cork Research Scientist Sales Development Executive Engineering Food Scientist Supply Chain Specialist Sales Consultant Pharmaceutical Clinical Research Medical Device Quality Auditor Manufacturing and Technology Manager Quality Specialist Regulatory Affairs Manager Biotechnologist Limerick Academic Biotechnology QA RA Engineer Formulation Scientist Quality Assurance Medical Advisor Life Science EHS Specialist Quality Assurance Officer Project Engineer Research and Development Scientist Dublin West Validation Specialist Equipment Engineer Manufacturing Coordinator Process Engineer Regulatory Affairs Specialist PhD Academic Quality Systems Lead Quality Control Manager QA Executive Contract QA Manager Account Manager EHS Engineer Bioprocess Engineer Sligo Automation Software Controls Manager Biopharmaceutical Scientific R and D Manager Biostatistician Manufacturing Engineer Dublin South Sales Specialist Life Science Planner Supply Chain Coordinator Supply Chain Microbiology Quality Control Supervisor Medical Affairs Medical Director Chemistry Senior Research and Development Engineer Galway Quality Systems Specialist Biochemist MES Consultant Principal Scientist Scientific Sales QC Analyst Validation Scientist Kildare Regulatory Affairs Regulatory Affairs QA Supervisor Validation Manager Automation Engineer Healthcare Process Development Engineer Dublin North Project Lead Supply Chain Administrator Connected Health Validation Engineer Senior Scientist Sales Executive