Overview
Regulatory Affairs Supervisor & Specialist Jobs in Heliopolis, Cairo, Egypt at Optimarc Pharma
Title: Regulatory Affairs Supervisor & Specialist
Company: Optimarc Pharma
Location: Heliopolis, Cairo, Egypt
Regulatory Affairs Supervisor
🔍 *Key Responsibilities*:
• Prepare and submit all documents required for import approvals, customs release, and exemptions.
• Follow up and respond to Health Authorities’ inquiries until final approvals are granted.
• Handle all Health Authorities visits (EDA & NFSA).
• Stay updated with new Health Authority regulations.
• Support the Marketing team with Health Authority-related inquiries.
• Prepare registration dossiers for company products.
• Maintain records for submitted documents and approvals.
• Issue ACID requests and manage Nafeza platform-related issues.
• Oversee EDA audit visits ensuring compliance and audit readiness.
• Supervise the regulatory team and manage their work plan.
🎓 *Qualifications*:
• Bachelor’s degree in Pharmacy.
• Fluency in English and Arabic (spoken & written).
• 3+ years of Regulatory Affairs experience (Raw Materials; Finished Products preferred).
• High level of accuracy.
• Strong communication and negotiation skills.
• Effective problem-solving and time management abilities.
💼 *Benefits*:
• Competitive salary.
• Medical insurance.
• Yearly bonus.
Regulatory Affairs Specialist
🔍Key Responsibilities:
• Prepare and submit all documents required for importation approvals, customs release and customs exemptions.
• Follow up and respond to all the health authorities’ inquiries in a timely manner until granting the final approvals.
• Responsible for handling all the health authorities visits (EDA & NFSA).
• Keep up-to-date with all health authorities’ new regulations.
• Support the marketing team in any inquiry related to the health authorities.
• Prepare the registration dossier for the company products.
• Keep track record for all the submitted documents and all the approvals.
🎓Qualifications:
• Pharmacy Bachelor Degree Holder.
• Proficiency in spoken & written English and Arabic.
• 2-3 years Regulatory Affairs experience.
• High accuracy level.
• Excellent communication and negotiation skills.
• Problem solving and time management skills.
🌟Benefits:
• Competitive Salary.
• Medical Insurance.
• Yearly Bonus.
