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

Regulatory Affairs Specialist

Regulatory Affairs Specialist Our client, a global medical device organisation requires a Regulatory Affairs Specialist to join their Regulatory Affairs Team. The Regulatory Affairs Specialist will report directly into the Regulatory Affairs Manager. Responsibilities • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required • Ensure a thorough understanding of the products they are assigned...

Location: Limerick,
Regulatory Affairs Specialist
Limerick Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client, an Irish based organisation are currently recruiting for a Senior Regulatory Affairs Specialist to join their team on a permanent basis. There is opportunity for remote working after some time in the role. Reporting to the Regulatory Affairs Manager of Warburton Technology, Responsibilities • Ensure compliance to all relevant regulations and should have knowledge and experience of filing EU Part 2 Quality dossiers for Injectable sterile products, as well as the ability to project manage the CMC portion of a US FDA NADA ap...

Location: Kerry,
Senior Regulatory Affairs Specialist
Kerry Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client is an international pharmaceutical discovery organisation and they are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis. The ideal candidate will be a dynamic individual, who is self-driven, organized and capable of working on their own initiative in a start-up environment. Responsibilities • Coordinate, prepare and be accountable for all regulatory affairs related activities such as clinical trial applications, organization and preparation of regulatory advice meetings and compilation...

Location: Dublin,
Regulatory Affairs Manager
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath 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.