Regulatory Affairs Specialist

Job description / Role

• To work on product registration, preparing full dossiers, verifying compliance of each product details with the required regulations and standards as per country.
• Prepare submissions of license variations and renewals, ensuring that deadlines are strictly met.
• Prepare and submit analysis requirements to MOH Laboratory and do proper follow-up.
• Follow up with principal companies and authorities as required to accelerate registration or approval processes.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Providing regulatory support and coordinate with our clients.
• Provide regular updates on post submission for RA manager and principal companies.
• Review and keep updated with company practice and system.
• Maintaining adequate documentation system, in addition to creating and updating projects database.