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Hot Regulatory Affairs Jobs

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Search Results for Regulatory Affairs Executive

Job Title.	Location	Salary	Actions
Regulatory Affairs Technical Manager remote working Regulatory Affairs Technical Manager 100% remote working Our client, an animal health organisation, are currently recruiting for a Regulatory Affairs Technical Manager to join their team. This is a super opportunity for an experienced Regulatory professional from an animal health or pharmaceutical background to work 100% remotely. Responsibilities Responsible for preparation of the Part 1 and CMC/Part 2 files for dossiers for Marketing authorisations Create and oversee studies needed, including technical/scientific input for pharmaceutical studies needed... Location: Kerry, Regulatory Affairs Technical Manager remote working	Kerry	Not Disclosed
Regulatory Affairs Officer Regulatory Affairs Officer Our client, an animal health company based in Kerry are currently recruiting for a Regulatory Affairs Officer to join their team. This is a super opportunity for a candidate with 1-2 years’ experience in Regulatory affairs to gain more in-depth exposure to Regulatory Affairs. Our clients offices will be based in Killarney, Co. Kerry and you will be required to be on site for this role. Responsibilities Project manage marketing authorization applications internationally, dossier preparations and be responsible for regulatory filing Pro... Location: Kerry, Republic of Ireland, Regulatory Affairs Officer	Kerry	Not Disclosed
Clinical Publisher Associate Clinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide... Location: Cork, Clinical Publisher Associate	Cork	Not Disclosed
Regulatory Affairs Specialist Regulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re... Location: Cork, Regulatory Affairs Specialist	Cork	Not Disclosed

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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.

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