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Search Results for Regulatory Affairs Specialist
Regulatory Affairs Manager (Food)Our client is a world leader in the Food sector. They are currently seeking an experienced Regulatory Manager to manage and develop a team of Regulatory Technologists, Senior Technologists and Specialists. The successful person shall improve regulatory processes, ensuring efficient, accurate and timely delivery of technical documentation to customers across EMEA. They will also ensure that products meet national and international legislation requirements. Role/Responsibilities: • Full understanding of relevant regulations globally - with a particular focus on EU, M...
Regulatory Affairs Specialist Career Profile
Regulatory Affairs SpecialistThere are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.
- Regulatory Affairs Assistant - €25,000 - €28,000
- Regulatory Affairs Officer - €32,000 - €39,000
- Regulatory Affairs Specialist - €40,000 - €55,000
- Regulatory Affairs Manager - €60,000 - €80,000
- Regulatory Affairs Director - €85,000 +
- 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 pharmaceutical 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.
- 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.