
Regulatory Affairs Specialist
1 day ago
Regulatory Affairs Specialist Role
\This position involves a range of responsibilities, including conducting and devising product trials, obtaining licenses for the product and ensuring it meets regulations, writing product labels and accompanying information leaflets.
\The role also entails studying scientific and legal documents, gathering, evaluating, organising, managing and collating information in various formats.
\Additionally, you will need to ensure compliance with regulations set by the Drug Regulatory Authority Pakistan (DRAP), maintain familiarity with company product ranges, plan, undertake and oversee product trials and regulatory inspections.
\Staying up-to-date with changes in regulatory legislation and guidelines is also crucial, as is analysing complicated information, including trial data.
\Other responsibilities include offering advice about company policies, practices and systems, obtaining marketing permission, outlining requirements for labelling, storage and packaging.
\Furthermore, this role involves liaising and negotiating with regulatory authorities, providing advice about regulations to manufacturers/scientists and writing clear and comprehensible product information leaflets and labels.
\Maintaining quality standards and meeting strict deadlines are essential aspects of this position.
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