Job Description
JOB DETAILS
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
FUNCTIONAL AREA
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