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CEO Medical Device Start Up
Republic of Ireland
Market Access Manager
Dublin City Centre
Principal Scientist
Dublin South
QA Specialist
Dublin West
QA Manager
Dublin West
Senior Chemist
Dublin North
Hospital Sales Specialist
Republic of Ireland
Snr Process Engineer
Dublin North
R&D Engineer
Galway
QA Manager
Meath
Qualified Person
Dublin West
QA Manager Biologics
Dublin West
Head of Quality
Dublin West
Program Manager
Westmeath
Technical Sales Engineer
Republic of Ireland
Snr QA Specialist
Dublin South
Microscopy Product Specialist
Republic of Ireland
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Regulatory Affairs Specialist
Job Title. Location Salary Actions

Regulatory Affairs Manager (Food)

Our client is a world leader in the Food sector. They are currently seeking an experienced Regulatory Manager to manage and develop a team of Regulatory Technologists, Senior Technologists and Specialists. The successful person shall improve regulatory processes, ensuring efficient, accurate and timely delivery of technical documentation to customers across EMEA. They will also ensure that products meet national and international legislation requirements. Role/Responsibilities: • Full understanding of relevant regulations globally - with a particular focus on EU, M...

Location: Kildare,
Regulatory Affairs Manager (Food)
Kildare Not Disclosed

Regulatory Affairs Manager Medical Devices

Regulatory Affairs Manager Medical Devices Our client, a global medical device organisation requires a Regulatory Affairs Manager to join their Regulatory Affairs Team on a permanent basis. The Regulatory Affairs Manager will report into the Director of Regulatory Affairs. The ideal candidate will have people management experience and experience in ISO13485. Responsibilities • Supervising the day to day workload and operational issues of the regulatory affairs team which includes setting team and individual objectives, carrying out performance appraisals, generating trai...

Location: Limerick,
Regulatory Affairs Manager Medical Devices
Limerick Not Disclosed

Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST Our client a Galway based medical device start up company is recruiting an RA Specialist. The successful candidate will work on

Location: Galway,
Regulatory Affairs Specialist
Galway Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
European Data Protection Officer Limerick 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.