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

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 & Labelling Specialist

Regulatory Affairs & Labelling Specialist Our client, a Irish owned organisation are currently recruiting for a Regulatory Affairs and Labelling Specialist to join their team. This is a permanent opportunity and the successful candidate will report directly into the Head of Quality and Regulatory Affairs. Responsibilities ·Execute and complete tasks and deliverables for CE marking activities as required to IVD directive ·Provide update and maintain status of product registration and notifications ·Provide documentation and certifications upo...

Location: Tipperary,
Regulatory Affairs & Labelling Specialist 		Tipperary 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
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Senior Director, Regulatory Affairs Dublin Not Disclosed
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Regulatory Affairs Officer Career Profile

Regulatory Affairs Officer


The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer


  • Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
  • Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
  • Preparation of dossiers to obtain CE marking for medical devices.
  • Ensuring Labelling complies with appropriate legislation.
  • Ensure approved regulatory requirements are enforced in-house.
  • Participate in the development of electronic submission of dossiers.
  • Provide support to R&D projects; including new product introductions, changes to existing products and processes.
  • Liaise with suppliers, clients, development partners and regulatory bodies.
  • Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
  • Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.