Regulatory Affairs Specialist Egypt

Company Description: Cerapie Pharma is a well-established Canadian pharmaceutical manufacturer known for its commitment to quality, safety, and regulatory compliance. The organization focuses on developing and producing pharmaceutical products that meet rigorous national and international standards. Team members collaborate across functions to support innovation, continuous improvement, and reliable product supply. Joining Cerapie Pharma offers opportunities to contribute to patient well-being while working in a structured, professionally driven environment.

Location: Egypt

Department: Regulatory Affairs

Reports to: VP - MEA

Job Purpose

We are looking for an experienced Regulatory Affairs Specialist – Egypt to manage pharmaceutical/Nutraceuticals product registration and regulatory activities in Egypt. The candidate should have strong knowledge of Egyptian Drug Authority (EDA) regulations and procedures, with established professional relationships with relevant regulatory stakeholders.

Key Responsibilities

• Manage the end-to-end registration and re-registration of pharmaceutical/Nutraceuticals products with the Egyptian Drug Authority (EDA).
• Prepare, review, submit, and follow up CTD registration dossiers and related regulatory documents.
• Ensure all submissions comply with the latest Egyptian regulatory requirements and guidelines.
• Coordinate with manufacturers and internal teams to obtain required registration documents, certificates, samples, artworks, and technical information.
• Handle EDA queries, deficiencies, clarification letters, and regulatory comments and ensure timely responses.
• Follow up the progress of registration applications and maintain an updated registration tracker.
• Manage variations, renewals, transfers, manufacturing site changes, and other post-registration activities.
• Monitor changes in Egyptian pharmaceutical regulations and communicate their impact on the company's products and registration strategy.
• Coordinate with EDA departments and relevant committees throughout the registration process.
• Maintain professional relationships with key EDA regulatory stakeholders and decision makers, while ensuring all interactions remain compliant and professional.
• Support the regulatory assessment of new products and advise management on registration feasibility, timelines, requirements, and potential regulatory challenges.
• Work closely with QA, Medical, Supply Chain, Commercial, and international regulatory teams.
• Support preparation of regulatory strategies for new product launches in Egypt.

Required Qualifications & Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field.
• 5+ years of pharmaceutical Regulatory Affairs experience in Egypt.
• Strong practical experience with EDA pharmaceutical registration procedures.
• Good knowledge of CTD/eCTD dossiers and pharmaceutical registration requirements.
• Experience with generic pharmaceutical products and imported products is highly preferred.
• Strong experience in handling EDA queries, deficiencies, variations, renewals, and registration follow-up.
• Established professional network and strong working relationships with relevant EDA stakeholders.
• Good understanding of Egyptian pharmaceutical legislation and regulatory guidelines.
• Excellent communication, negotiation, follow-up, and problem-solving skills.
• Fluent Arabic and good English.

Key Success Factors

The ideal candidate should be well connected within the Egyptian regulatory environment, highly proactive, and capable of moving registration files forward independently. Strong knowledge of EDA procedures and the ability to anticipate regulatory requirements will be essential.

The role is particularly suitable for an RA professional who can combine strong technical regulatory expertise with effective stakeholder management and follow-up.

Interested candidates are invited to send their CV to [Confidential Information].