Regulatory Affairs Officer
Titlis Pharma, Pakistan

• 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.

• Analytical and problem-solving skills;
• The ability to grasp new concepts quickly and to assimilate data from a range of scientific areas;
• Written and oral communication skills;
• Considerable understanding of both legal and scientific matters;
• Attention to detail

Job Rewards and Benefits