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Job Description
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Analyze product complaints and make recommendations for solutions
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Studying scientific and legal documents
- Gathering, evaluating, organizing, managing and collating information in a variety of formats
- Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency .
- Maintaining familiarity with company product ranges
- Planning, undertaking and overseeing product trials and regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
Job Requirements
- 2-4 years of experience