Senior Regulatory Affairs Specialist
Cairo,
Egypt
Klick is a trusted partner to global manufacturers, offering the B2B sector a distinguished range of innovative, high-quality raw materials complemented by outstanding client support. With over 20 years of experience in Egypt’s pharmaceutical industry, the Klick team combines deep market knowledge with specialized technical and logistical expertise. Leveraging our global network, we remain at the forefront of industry advancements, delivering exceptional ingredient solutions and cutting-edge offerings to our clients. Our commitment to excellence ensures our partners receive unparalleled value and market insights.
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
Responsibilities
- 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.
- Follow up and arrange with NODCAR/NFSA Approved testing labs in analyzing samples for Klick to ensure proper completion of their requirements.
Must Have
- Bachelor's degree in a related field (e.g., Pharmacy, Chemistry)
- Regulatory Documentation and Regulatory Submissions skills.
- Excellent written and verbal communication skills.
- Proficiency in all aspects of Regulatory Affairs.
Nice to have
- Experience in the pharmaceutical industry
What's great in the job?
- Great team of smart people, in a friendly and open culture
- No dumb managers, no stupid tools to use, no rigid working hours
- No waste of time in enterprise processes, real responsibilities and autonomy
- Expand your knowledge of various business industries
- Create content that will help our users on a daily basis
- Real responsibilities and challenges in a fast evolving company
Our Product
What We Offer
Each employee has a chance to see the impact of his work.
You can make a real contribution to the success of the company.
Several activities are often organized all over the year, such as weekly
sports sessions, team building events, monthly drink, and much more
Perks
A full-time position
Attractive salary package.
Trainings
12 days / year, including
6 of your choice.
Sport Activity
Play any sport with colleagues,
the bill is covered.
Eat & Drink
Fruit, coffee and
snacks provided.
