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

Global Labelling Technical Regulatory Affairs Lead (Associate Director)

Global Labelling Technical Regulatory Affairs Lead (Associate Director) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. Their office in Cork consists of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Medical, Clinical Trials, Finance, Information Technology and more. They provide a premium workspace across our ca...

Location: Cork,
Global Labelling Technical Regulatory Affairs Lead (Associate Director) 		Cork Not Disclosed

Senior Director Global Regulatory Lead Early Clinical Development

Senior Director Global Regulatory Lead Early Clinical Development Our client, a global pharma company, are currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to joint their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global...

Location: Cork,
Senior Director Global Regulatory Lead Early Clinical Development 		Cork Not Disclosed

Associate Director Clinical Regulatory Scientist

Associate Director Clinical Regulatory Scientist(Specialising in Paediatrics) Our client, a global pharma company are currently recruiting for an Associate Director Clinical Regulatory Scientist (Specialising in Paediatrics) to join their team and a permanent basis. As Associate Director Clinical Regulatory Scientist you will develop and execute the regulatory strategy for the US and Canadian markets. This role offers hybrid working. Responsibilities Develop, Update and Execute US and Canada Registration Strategy Initiate and Update Regulatory Strategy Doc...

Location: Cork,
Associate Director Clinical Regulatory Scientist 		Cork Not Disclosed

Principal Scientist Global Regulatory Affairs CMC

Principal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently recruting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site. This is a permanent role withhybrid working. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions. Resp...

Location: Cork,
Principal Scientist Global Regulatory Affairs CMC 		Cork Not Disclosed

Principal Scientist Global Regulatory Affairs CMC

Principal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and are currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC to join their team on a permanent basis. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration...

Location: Limerick,
Principal Scientist Global Regulatory Affairs CMC 		Limerick Not Disclosed

CMC Regulatory Principal Scientist

CMC Regulatory Principal Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration...

Location: Cork,
CMC Regulatory Principal Scientist 		Cork Not Disclosed

CMC Regulatory Senior Scientist

CMC Regulatory Senior Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissi...

Location: Cork,
CMC Regulatory Senior Scientist 		Cork 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.