Senior Reg Affairs Specialist Location: Galway, Mayo, Roscommon Salary: 55 - 65K


 

Senior Reg Affairs Specialist

My client is a leading developer and manufacturer of injectable pharmaceuticals both in Ireland and worldwide. With a product portfolio that includes over 20 pharamceutical products, this company distributes to more than 50 countries worldwide. Currently a vacancy has arisen for a Senior Reg Affairs Specialist.

OVERALL RESPONSIBILITIES:

• Responsible for the preparation of regulatory submissions, for various pharmaceutical products, to world wide markets.

PRIMARY/MAJOR RESPONSIBILITIES:

• Life cycle management and Maintenance of regulatory filings including annual reports and  supplements to US FDA.
• Preparation of registration submissions, in CTD format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and world wide, 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.

EDUCATIONAL REQUIREMENTS:

• Minimum education to Degree Status in one of the life sciences.

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.

SPECIAL SKILLS:

• Good interpersonal and communication skills both written and verbal.
• Strong technical background.
• Excellent organizations skills.

If you are interested in this position please apply online or contact Shane Brown on 01 6321865.

YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE

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