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

Director of Regulatory Affairs

Would you like to join a leading and successful medical device company in Ireland, to further develop your career? This is an excellent opportunity to work with leading technologies in the medical device industry, in a Strategic Director level role. TheDirector ofRegulatory Affairsis responsible for leading regulatory team, regulatory strategy, systems, and for ensuring that the company's products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable.&n...

Location: Republic of Ireland,
Director of Regulatory Affairs
Republic of Ireland Not Disclosed

Regulatory Affairs Specialist

Our client a medical device start-up looking to hire a Regualatory Affairs Specialist who will support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company. Role/Responsibilities: Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices).&nbs...

Location: Dublin,
Regulatory Affairs Specialist
Dublin Not Disclosed
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Regulatory Affairs Specialist Republic of Ireland Not Disclosed
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Regulatory Affairs Specialist Republic of Ireland Not Disclosed
Director, Regulatory Affairs (Pediatrics/Infectious Diseases) Dublin Not Disclosed
Regulatory Affairs Specialist Republic of Ireland Not Disclosed

Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)

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 biopharmaceutical 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.

Qualifications / 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.