أخصائي شؤون تنظيمية - أدوية

PHARAONIA Pharmaceutical is One of the top 30 pharmaceutical companies in the Egyptian market going to be one of the top 10 companies within years based on its new outstanding system and environment

The company produces more than 270 pharmaceutical brands at its huge factory at Borg El-Arab, Alexandria.

Exports its products to more than 12 countries.

A new and huge sterile area has been opened previous year with huge production capacity and characteristic production quality.

Recently Pharaonia Pharmaceuticals expanded its huge promotion team by opening 2 new strategic units to promote professionally its new strategic products.

VACANCY:

We are recruiting professional caliber to join the team as per the following details:

• Designation: Regulatory Affairs Specialist.
• Location : Industrial Area No.3 – Block 16 – Place No. 1 – Borg Alarab, Alexandria, Alexandria.
• Reporting : RA Manager.

Job Purpose:

This is position is centered on prepare, compile, and submit high-quality regulatory documentation to the Egyptian Drug Authority (EDA) to obtain and maintain local marketing authorizations for the company’s products. The role ensures full compliance with applicable local regulatory requirements throughout the product lifecycle.

A. ESSENTIAL DUTIES and RESPONSIBILITIES:

• Compile, format, and review scientific and technical data to prepare regulatory dossiers (CTD modules) for new product registrations, variations, and renewals within the local market.
• Prepare and submit local registration files to the EDA and manage all related follow-ups, including responses to agency deficiencies and queries.
• Maintain accurate, complete, and well-organized records of all local regulatory submissions, correspondence, approvals, and commitments.
• Review product labeling, package leaflets, and promotional materials to ensure compliance with current local regulatory requirements.
• Coordinate with internal stakeholders (R&D, Quality, Production, and Supply Chain) to collect, validate, and align required documentation for submissions.
• Monitor and stay up to date with local regulatory guidelines, circulars, and EDA updates, assessing their impact on the registered portfolio.

B. QUALIFICATIONS and EXPERIENCE:

• EDUCATION : Bachelor’s degree in Pharmacy or a related Life Science is required.
• EXPERIENCE :
• 1–3 years as Regulatory Affairs Specialist.
• Practical experience with CTD format and local electronic submission platforms.
• LANGUAGE : Good English proficiency both oral and writing.

C. COMPETENCIES and BEHAVIORS:

• Working with People.
• Delivering results & meeting customer expectations.
• Adapting & responding to change.
• Presenting & communicating.
• Learning & researching.

Sustainable commitment to talents through engaging and developing them in a career-growth driven organizational culture. With us, there are always opportunities to break new ground.

We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons.

We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.