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

CMC Regulatory Specialist

CMC Regulatory Specialist Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. ...

Location: Cork,
CMC Regulatory Specialist 		Cork 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

CMC-Development Regulatory Associate

CMC – Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding stra...

Location: Cork,
CMC-Development Regulatory Associate 		Cork Not Disclosed

Regulatory Affairs Specialist

Regulatory Affairs Specialist required for a Limerick based Medical Device facility. We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise. Compiles and communicates regulatory requirements...

Location: Limerick,
Regulatory Affairs Specialist 		Limerick Not Disclosed

Regulatory Affairs Specialist

Regulatory Affairs Specialist required for a Limerick based Medical Device facility. We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise. Compiles and communicates regulatory requirements %2...

Location: Limerick,
Regulatory Affairs Specialist 		Limerick Not Disclosed

Chief Technology Officer (CTO)

Chief Technology Officer (CTO) Our client, a biotech organisation establishing operations in Ireland, are currently recruiting for a Chief Technology Officer to join their business. The main task of the CTO is to lead the device development part of the drug-device combination product. The CTO is involved in the strategy and operationalization of the technical development and regulatory strategy. Responsibilities Related to device development, coordinates input from external regulatory affairs consultants and identifies and closes knowledge gaps Lead device-related ac...

Location: Dublin,
Chief Technology Officer (CTO) 		Dublin Not Disclosed

Regulatory Project Manager

Regulatory Project Manager Our client, a growing biotech organisation are currently recruiting for a Regulatory Project Manager to join their organisation on a permanent basis. As Regulatory Project Manager you will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. As Regulatory Project Manager you will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledg...

Location: Dublin,
Regulatory Project Manager 		Dublin Not Disclosed

Quality and Regulatory Affairs Manager

Quality & Regulatory Affairs Manager Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction. Responsibilities Provide Quality & Regulatory ...

Location: Dublin,
Quality and Regulatory Affairs Manager 		Dublin Not Disclosed
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Job Title Location Salary Actions
Senior Director, Regulatory Affairs (Biopharma) Dublin Not Disclosed
Senior Director, Regulatory Affairs (Biopharma) Dublin Not Disclosed
Senior Director, Regulatory Affairs (Biopharma) Dublin Not Disclosed
Senior Regulatory Affairs Specialist Dublin Not Disclosed
Associate Compliance Specialist - Manufacturing Limerick Not Disclosed
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Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.

Salary Scale:


  • Regulatory Affairs Assistant - €25,000 - €28,000
  • Regulatory Affairs Officer - €32,000 - €39,000
  • Regulatory Affairs Specialist - €40,000 - €55,000
  • Regulatory Affairs Manager - €60,000 - €80,000
  • Regulatory Affairs Director - €85,000 +

Role 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 pharmaceutical 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.

Industry 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.