Senior Regulatory Affairs / Regulatory Manager
February 4th, 2009
Tags: Annual Reports Attention To Detail Compliance Fda Healthcare Industry Knowledge Interpersonal Skills Medical Devices Oral Communication Skills Pharmaceutical Products Quality Assurance Quality Control Queries Registration Submissions Regulatory Activities Regulatory Affairs Regulatory Authorities Technical Background Undue Delays Variations West Of Ireland
Senior Regulatory Affairs Executive, based in the West of Ireland
Reporting to the Director of Regulatory Affairs
You will be responsible for:-
- 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.
- Preparation of registration submissions, in CTD format, for pharmaceutical products for approval by the US FDA and European Regulatory Authorities.
- Preparation of registration submissions for medical devices for approval in the US and EU.
- Maintenance of approvals, including the preparation of annual reports for US products.
- Preparation of applications for variations to existing approvals.
- Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
EXPERIENCE
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