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

Regulatory Officer

Our client is an exciting entrepreneurial research & development driven organisation, based in Drogheda. They are seeking a Regulatory Officer for a 9 month contract to cover a maternity leave. This role is responsible for product registration and document control across all global brands and markets. The position requires significant organisation skills, with cross functional engagement to ensure relevant documents are supplied on time and to a high standard. Role/Responsibilities: Register products for new markets, maintain and sub...

Location: Louth, Republic of Ireland,
Regulatory Officer
Louth Not Disclosed

Regulatory Officer

Life Science Recruitment are exclusively sourcing a Regulatory Officer for our client who are based in Limerick. The ideal candidate will have a BSc in molecular science with the ability and confidence to undertake all associated responsibilities. Role/Responsibilities: Prepare and maintain IVDR compliant technical files utilising information from cross functional teams. Review and approve project documentation and participate in R&D phase reviews across multiple projects. Coordinate risk management activities and file preparation. Communicate specific regulatory req...

Location: Limerick,
Regulatory Officer
Limerick 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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Director Regulatory Affairs Dublin Not Disclosed
Senior Regulatory Affairs Specialist Dublin Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed
CMC Regulatory Associate Cork Not Disclosed
CMC Regulatory Specialist Cork Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed

Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)

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 biopharmaceutical 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.

Qualifications / 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.