Regulatory Affairs Manager

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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