Key duties of the job include:
- 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 (MHRA)
- 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.