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

Senior Regulatory Affairs Specialist

Would you like to join a leading medical device company in Galway, in a regulatoey affairs role? If you have previous Regulatory Affairs experience working with class III medical devices, this could be the role for you. RESPONSIBILITES Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions. Teams with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to ex...

Location: Galway,
Senior Regulatory Affairs Specialist 		Galway Not Disclosed

Regulatory Affairs Specialist

Our client a medical device early stage company wishes to add a Regulatory Affairs Specialist to our team. The successful candidate will work with the Design, Quality and Regulatory teams to support all regulatory functions for both existing and new products. Role/Responsibilities • Contribute to the regulatory strategy plans for new products, including required Regulatory Agency approvals. • Provide regulatory input into labelling, test strategies for new product development, risk analysis, clinical, preclinical and marketing issues. • Planning,...

Location: Cork,
Regulatory Affairs Specialist 		Cork Not Disclosed
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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.