Regulatory Affairs Specialist

About the role

MKadvance is seeking a Regulatory Affairs Specialist to ensure its products meet local and international regulatory standards. The role is based in Cairo with a hybrid work arrangement.

Key responsibilities

• Prepare, review, and maintain regulatory documentation, ensuring accuracy and compliance.
• Monitor regulatory requirements, coordinate submissions to authorities, and track approval timelines.
• Collaborate with internal teams and external bodies to address queries and support product registrations.
• Manage post‑market regulatory activities, maintain databases, and support audits and inspections.

Required profile

• Bachelor’s degree in Pharmacy, Science, or a related field.
• 3+ years of experience in Regulatory Affairs, including submissions to health authorities and lifecycle management.
• Strong analytical, documentation, and organizational skills with attention to detail.
• Effective written and verbal communication in English and Arabic.

Required skills

• Regulatory documentation preparation
• Regulatory submissions and tracking
• Technical file and registration dossier preparation
• Regulatory compliance for medical devices/electrophysiology products
• Office software and regulatory tracking tools