Assistant Manager Regulatory Affairs

Genetics Pharmaceuticals Pvt Ltd; Lahore; On-site; PKR 1,400,000 - 2,000,000; Full time

Job description

Genetics Pharmaceuticals Pvt Ltd, Pakistan

From conducting and devising product trials, to getting licenses for the product and ensuring it meets regulations, to actually writing the product labels and accompanying information leaflets.

Studying scientific and legal documents

Gathering, evaluating, organising, managing and collating information in a variety of formats

Ensuring compliance with regulations set by the DRAP ( Drug Regulatory Authority Pakistan)

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