close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Search Results for Regulatory Affairs Executive
Job Title. Location Salary Actions

Regulatory Officer (Maternity Contract)

Regulatory Officer - Maternity Cover Our client is a research & development driven organisation, based in Drogheda. They are seeking a Regulatory Officer for a Maternity contract. This role is responsible for product claims & communication compliance across all global brands and markets. The position requires creative & scientific experience and will engage cross functionally to ensure compliance to relevant regulations & adherence to company policies & brand guidelines. On the job training will be provided for the sucessful person.&...

Location: Louth, Republic of Ireland,
Regulatory Officer (Maternity Contract) 		Louth 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
Senior Manager (Clinical Quality and Compliance) Dublin Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed
Senior Manager (Clinical Quality and Compliance) Dublin Not Disclosed
Senior Manager (Clinical Quality and Compliance) Dublin Not Disclosed
Senior Manager (Clinical Quality and Compliance) Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
CMC Regulatory Associate Cork Not Disclosed
CMC Regulatory Specialist Cork Not Disclosed
Director Regulatory Affairs Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Subscribe RSS feed for this search

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.