Role Description

This is a full-time, on-site role for a Senior Regulatory Affairs Specialist located in Qesm 1st Nasser City. The Senior Regulatory Affairs Specialist will ensure an efficient and effective registration process for Klick products to allow fast time to market and will be responsible for preparing and submitting regulatory documentation, ensuring compliance with regulatory requirements, and managing regulatory submissions. The individual will also work on maintaining regulatory compliance and handling all aspects of regulatory affairs as follows: -

• Responsible for the whole registration process and follow up the status of products under registration with EDA (Egyptian Drug Authority) according to relevant SOP, including but not limited to submitting the registration documents, paying registration fee and booking appointments, arranging inspectors' visits, to ensure consistent processing and handling any obstacles.
• Follow up all products status with EDA, and follow up products approvals and release for (raw material, finished products, product importation approvals and release docs.)
• Maintain the regulatory files/database updated in a good order including but not limited to tracking changes in documents submitted to the concerned authorities.
• Follow up with EDA and NFSA for any related issues related to Klick, and acting as Klick representative in front of EDA reception desk and attend in any requirements, appeals, inquires and complaints, etc and submit the necessary documents.
• Compile all documents required for license renewals, updates and preparation of registration files for any new products or any relevant files.
• Follow up and arrange with NODCAR/NFSA Approved testing labs in analyzing samples for Klick to ensure proper completion of their requirements.
• Responsible for obtaining import approvals while working as a communication channel between Klick, EDA and any other registration agents.
• Manage API listing process in whitelist, handling all communication and correspondence between the authorities and API manufacturers.

Qualifications

• Regulatory Documentation and Regulatory Submissions skills.
• Experience in Regulatory Compliance and Regulatory Requirements.
• Proficiency in all aspects of Regulatory Affairs.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a team
• Bachelor's degree in a related field (e.g., Pharmacy, Chemistry, Life Sciences)
• Experience in the pharmaceutical industry is a plus.