Regulatory Affairs Officer

Job Summary

Support the Regulatory Affairs team in registering, maintaining, and ensuring compliance of health products (pharmaceuticals, medical devices, nutraceuticals). Assist in preparing regulatory submissions, coordinating with authorities, and ensuring timely approvals.

Primary Duties

• Assist in dossier preparation for product registration, including quality, non-clinical, and administrative sections.
• Liaise with internal functions (QA, Medical, Supply Chain) to gather required documentation.
• Monitor regulatory changes and share updates impacting submissions / market maintenance.
• Prepare labelling and packaging compliance checks against local regulations.
• File applications for registration, renewal, variations, cancellations.
• Track application status and coordinate required follow-up with regulators.
• Organize regulatory documentation repository for audit readiness.
• Assist with import permit processes and coordination with local custodian agents.

Skills & Requirements

• Bachelor’s degree in Pharmacy, or related.
• Familiarity with pharmaceutical dossiers and regulatory requirements.
• Highly organized, with good time management and communication.
• Experience with regulatory databases and online submissions.

Job Type: Full-time