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

Scientific Officer Compliance (Cosmetics)

Scientific Officer Compliance (Cosmetics) Our client, a large regulatory body are currently recruiting for a Scientific Officer to join their team. As Scientific Officer you will assist in the investigation of compliance and vigilance cases; the examination and evaluation of safety assessments, including the toxicological component, of Product Information Files; evaluation of analytical reports received as a result of compositional analysis as well as submissions received through post-market surveillance. This includes an evaluation and assessment of the likely hazards assoc...

Location: Dublin,
Scientific Officer Compliance (Cosmetics)
Dublin Not Disclosed

CMC Regulatory Associate

CMC Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission rel...

Location: Cork,
CMC Regulatory Associate
Cork Not Disclosed
Other Regulatory Affairs Jobs
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Director Regulatory Affairs Dublin Not Disclosed
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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.