Regulatory Affairs Representative

About the Job

• 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