Senior Regulatory Specialist

About the role

We are seeking a Senior Regulatory Specialist to lead the preparation, submission, and lifecycle management of pharmaceutical dossiers for the Egyptian Drug Authority. The role involves close collaboration with cross‑functional teams to ensure regulatory compliance and timely product approvals.

Key responsibilities

• Prepare, review, and submit high‑quality CTD/eCTD dossiers for new registrations, renewals, variations, and post‑approval changes.
• Manage end‑to‑end product lifecycle activities, including CMC variations, source transfers, labeling updates, and responses to Health Authority Questions.
• Monitor regulatory intelligence, assess risks, and define strategies aligned with business objectives.
• Collaborate with Quality Assurance, Supply Chain, R&D, Marketing, and Commercial teams to ensure alignment with global standards.
• Maintain regulatory documentation databases, drive process improvements, and support digital initiatives.
• Mentor junior regulatory colleagues and act as a subject‑matter expert.

Required profile

• Bachelor’s degree in Pharmacy.
• 3–5 years of regulatory affairs experience in the pharmaceutical industry.
• Proven track record of product registration and lifecycle management with the Egyptian Drug Authority.

Required skills

• CTD/eCTD dossier preparation.
• Regulatory intelligence monitoring.
• Regulatory documentation management.