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Job Description
1) Compile and maintain regulatory documentation databases or systems.
2) Coordinate efforts associated with the preparation of regulatory documents or submissions.
3) Analyze product complaints and make recommendations regarding their reportability.
4) Develop or conduct employee regulatory training.
5) Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Job Requirements
- studying scientific and legal documents
- gathering, evaluating, organising, 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
- analysing complicated information, including trial data
- offering advice about company policies, practices and systems
- obtaining marketing permission
- outlining requirements for labelling, storage and packaging
- using a variety of specialist computer applications
- liaising and negotiating with regulatory authorities
- providing advice about regulations to manufacturers/scientists
- writing comprehensible, user-friendly, clear product information leaflets and labels
- ensuring that quality standards are met and submissions meet strict deadlines
- preparing documentation.
