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

Regulatory Affairs Technical Manager remote working

Regulatory Affairs Technical Manager 100% remote working Our client, an animal health organisation, are currently recruiting for a Regulatory Affairs Technical Manager to join their team. This is a super opportunity for an experienced Regulatory professional from an animal health or pharmaceutical background to work 100% remotely. Responsibilities Responsible for preparation of the Part 1 and CMC/Part 2 files for dossiers for Marketing authorisations Create and oversee studies needed, including technical/scientific input for pharmaceutical studies needed...

Location: Kerry,
Regulatory Affairs Technical Manager remote working
Kerry Not Disclosed

Regulatory Affairs Officer

Regulatory Affairs Officer Our client, an animal health company based in Kerry are currently recruiting for a Regulatory Affairs Officer to join their team. This is a super opportunity for a candidate with 1-2 years’ experience in Regulatory affairs to gain more in-depth exposure to Regulatory Affairs. Our clients offices will be based in Killarney, Co. Kerry and you will be required to be on site for this role. Responsibilities Project manage marketing authorization applications internationally, dossier preparations and be responsible for regulatory filing Pro...

Location: Kerry, Republic of Ireland,
Regulatory Affairs Officer
Kerry Not Disclosed

Clinical Publisher Associate

Clinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide...

Location: Cork,
Clinical Publisher Associate
Cork Not Disclosed

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.