Regulatory Affairs Manager

Regulatory Affairs Manager is responsible for leading and managing all regulatory activities related to the registration, re-registration, and lifecycle management of Otsuka products with the Egyptian Drug Authority (EDA) and the Ministry of Health (MOH).

- This role involves developing and executing the regulatory strategy for both pharmaceutical and nutraceutical/food supplement products, ensuring full compliance with local and international regulatory requirements, including those of the National Food Safety Authority (NAFSA).

-The incumbent will provide strategic guidance to senior management, ensuring alignment with MOH/EDA regulations and global Otsuka standards while maintaining continuous market access for all company products.

Qualifications and Experience:

• Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences (Master’s degree preferred).
• Experience: Minimum of 15 years of experience in regulatory affairs within the pharmaceutical industry, including at least 3 years in a managerial role.
• Knowledge:
• Excellent communication and negotiation skills with regulatory authorities.
• Strong leadership skills
• Strong attention to detail
• Strong Analytical thinking and problem-solving capabilities.
• Fluency in English
• Proficiency in Microsoft Office and regulatory submission tools.