Optimed Pharma is hiring a Regulatory Affairs Specialist in Cairo, Egypt, as part of its new expansion. The company is looking for a qualified and experienced professional with a background in pharmacy, pharmaceutical sciences, or a related life-sciences field to support regulatory activities, product registration, and compliance.

This opportunity is suitable for candidates with pharmaceutical regulatory affairs experience, knowledge of Egyptian pharmaceutical regulations, and expertise in preparing and maintaining regulatory documentation.

Job Overview

• Company Name: Optimed Pharma
• Job Title: Regulatory Affairs Specialist
• Department: Regulatory Affairs
• Job Location: Cairo, Egypt
• Industry: Pharmaceutical Industry
• Experience Required: 2+ years
• Qualification: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related life-sciences field
• Hiring Type: New Expansion
• Application Mode: Email
• Official Website: Optimedpharma.com
• Application Email: hr@optimedpharma.com

Educational Qualifications

Candidates should possess a bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related life-sciences discipline. Applicants should have a sound understanding of pharmaceutical regulations, product registration procedures, and regulatory documentation requirements.

Experience Requirements

Applicants must have at least 2 years of experience in Regulatory Affairs within the pharmaceutical industry. Experience in preparing regulatory dossiers, maintaining product documentation, and coordinating regulatory submissions will be valuable for this position.

Key Responsibilities

The selected candidate may be responsible for the following activities:

• Preparing, reviewing, and maintaining regulatory dossiers and pharmaceutical product documentation.
• Supporting pharmaceutical product registration and renewal procedures.
• Ensuring regulatory submissions comply with applicable Egyptian requirements.
• Maintaining documentation related to the Egyptian Drug Authority (EDA).
• Supporting regulatory requirements for products that fall under the National Food Safety Authority (NFSA), where applicable.
• Monitoring regulatory documentation, submission timelines, and compliance requirements.
• Coordinating with internal teams to ensure accurate and timely regulatory submissions.
• Maintaining organized regulatory records and ensuring attention to detail throughout the documentation process.

Note: These responsibilities are based on the advertised role and its requirements; the final duties may be defined by the employer.

Required Skills and Knowledge

Candidates should have the following skills and competencies:

• Knowledge of pharmaceutical regulatory affairs and product registration procedures.
• Familiarity with Egyptian Drug Authority (EDA) regulations.
• Understanding of National Food Safety Authority (NFSA) requirements is an advantage, particularly for food supplements and related products.
• Experience preparing and maintaining regulatory dossiers.
• Strong documentation and record-management skills.
• Excellent attention to detail and organizational abilities.
• Good written and verbal communication skills.
• Ability to coordinate regulatory activities and manage documentation deadlines.

Salary and Benefits

Optimed Pharma highlights the following benefits in its recruitment announcement:

• Competitive compensation package.
• Healthy working environment.
• Fast career-development pathway.
• Medical and social insurance.
• Career growth opportunities.

The exact salary, working hours, and other employment conditions have not been specified in the advertisement. Candidates should confirm these details directly with the employer during the recruitment process.

How to Apply for Optimed Pharma Recruitment 2026

Interested and eligible candidates should prepare an updated CV highlighting their pharmaceutical education, regulatory affairs experience, product registration knowledge, and regulatory documentation skills.

Application Email: hr@optimedpharma.com

Email Subject: Application for Regulatory Affairs Specialist – Cairo

Applicants should ensure that their CV contains accurate information about their qualifications, relevant experience, and technical competencies before submitting it.

Company Website: Optimedpharma.com

Candidates are advised to verify the vacancy and employment terms directly with the company before sharing sensitive personal information.

Technical FAQs

1. What is the role of a Regulatory Affairs Specialist in the pharmaceutical industry?

A Regulatory Affairs Specialist helps ensure that pharmaceutical products meet applicable regulatory requirements. The role involves preparing and maintaining regulatory dossiers, coordinating product registration submissions, managing documentation, and supporting compliance throughout the product lifecycle.

2. What is the Egyptian Drug Authority (EDA), and why is it important for this position?

The Egyptian Drug Authority (EDA) is Egypt’s regulatory authority responsible for regulating pharmaceutical products and related activities within its remit. Knowledge of applicable EDA requirements is important for preparing submissions, supporting product registration, and maintaining regulatory compliance in Egypt.

3. What is a pharmaceutical regulatory dossier?

A regulatory dossier is a structured collection of documents submitted to a regulatory authority to support the registration or approval of a pharmaceutical product. Depending on the product and applicable requirements, it may include administrative information, quality documentation, manufacturing details, analytical data, and relevant safety and efficacy information.

4. What is the difference between EDA and NFSA regulatory requirements?

The EDA regulates pharmaceutical products and other products within its statutory scope, while the NFSA oversees food safety matters, including relevant food products and supplements within its remit. The applicable authority depends on the product category and current Egyptian regulations. Candidates should understand the requirements relevant to the products they will handle.

5. What technical skills are important for a Regulatory Affairs Specialist?

Important technical skills include regulatory dossier preparation, product registration documentation, regulatory submission management, document control, compliance tracking, and knowledge of applicable pharmaceutical regulations. Attention to detail, effective communication, and the ability to maintain accurate records are also essential.

Conclusion

Optimed Pharma’s recruitment for a Regulatory Affairs Specialist in Cairo, Egypt, presents an opportunity for pharmaceutical and life-sciences graduates with at least two years of relevant regulatory affairs experience. Candidates with knowledge of EDA regulations, pharmaceutical product registration, and regulatory dossier management may be well suited to this position.

Eligible applicants can submit their updated CV to hr@optimedpharma.com for consideration. Applicants should confirm the current vacancy status and all employment details directly with the employer.