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

CMC Regulatory Affairs Senior Manager

CMC Regulatory Affairs Senior Manager Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a CMC Regulatory Affairs Senior Manager to join their global regulatory affairs group on a permanent basis. As CMC Regulatory Affairs Senior Manager you will manage the CMC submission management processes by leveraging expertise to optimize internal processes and tools. Responsibilities Manage the CMC submission management processes by leveraging expertise to optimize internal processes and tools processes and tools. Anticipate and resolve pr...

Location: Cork,
CMC Regulatory Affairs Senior Manager
Cork Not Disclosed

Regulatory Affairs Manager (EMEA)

A Regulatory Affairs Manager (EMEA) is required to join a leadingMedical Device organisationin Athlone . Your role: As the Regulatory Affairs Manager you will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for company products globally. Your responsibilities: Primary responsibility for regulatory affairs in the EMEA region. Pursue relevant information pertaining to new developments in regulatory affairs by maintaining contact w...

Location: Roscommon,
Regulatory Affairs Manager (EMEA)
Roscommon Not Disclosed

Regulatory Affairs Project Leader

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork . The Regulatory Affairs Project Leader is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Your duties: As the Regulatory Affairs Project Leader, you will serve as a technical expert on Regulatory Affairs matters and will be responsible for providing assistance in the preparation and submission of global regulatory documents with little to no supervision. You may act as a team le...

Location: Cork,
Regulatory Affairs Project Leader
Cork Not Disclosed

Senior Associate Regulatory Affairs

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. This is an excellent position fo

Location: Dublin,
Senior Associate Regulatory Affairs
Dublin Not Disclosed
Other Regulatory Affairs Jobs

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.