Job Title.	Location	Salary	Actions
Senior Regulatory Officer Senior Regulatory Officer Our client, a global healthcare organisation, requires a Senior Regulatory Officer to join their team. This is an excellent opportunity to work within the growing biologics space in Ireland. Responsibilities • Execute operational labelling activities required for all generic and brand products for multiple product types • Ensure appropriate key goals are met on time, and maintain Compliance of regulatory based labelling: Summary of Product characteristics, Package leaflet and Prescribing Information • Maintain current kn... Location: Dublin, Senior Regulatory Officer	Dublin	Not Disclosed
Senior Regulatory Affairs Officer Our client – a global pharmaceutical company – are seeking a Snr RA Officer for their Commercial base in west Dublin. Responsibilites: • Obta Location: Dublin West, Senior Regulatory Affairs Officer	Dublin West	Not Disclosed

Job Title	Location	Salary	Actions
Regulatory Affairs Manager (Food)	Kildare	Not Disclosed
Head of Quality & Regulatory Affairs	Dublin	Not Disclosed
Regulatory Affairs Specialist	Galway	Not Disclosed
Regulatory Affairs Manager (Food)	Kildare	Not Disclosed
Regulatory Affairs Manager (Food)	Kildare	Not Disclosed
Regulatory Affairs Specialist	Galway	Not Disclosed
Regulatory Affairs Specialist	Galway	Not Disclosed

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.