Regulatory Affairs Vacancy At Al Andalous Medical Company

Export Regulatory Affairs Specialist At Al Andalous Medical Company

Al Andalous Medical Company one of the top 20 pharmaceutical companies in Egypt is now hiring :
” Export Regulatory Affairs Specialist”.

– job Description:

– Facilitate the company’s entry into new and diverse markets by overseeing the registration process.
– Develop and implement the regulatory procedures required for entering various export markets, both new and established, and ensure compliance with registration.
– Compile and prepare Export Registration documentation for different countries, as well as re-registration dossiers for products.
– Establish and uphold a strong registration track record in export markets, consistently meeting the necessary requirements for successful registrations.
– Respond promptly to any necessary product modifications, such as changes in packaging, formula, or name, in order to streamline the registration process across different countries.
– Cultivate and maintain positive relationships with both internal and external stakeholders.
– Monitor and manage all stages of export registration, working closely with agents and the Ministry of Health in different countries. This includes conducting Stability Studies, Bioequivalence Studies, preparing inserts and packs, performing analyses, and pricing determination.
-Ensure that all registration activities conducted by Al Andalous Pharmaceutical Company are in full compliance with both company policies and relevant national laws and regulations.
-Maintain a strict level of confidentiality regarding the content of registration files.
-Thoroughly review compiled registration files to verify their compliance with the applicable regulations of each market, paying close attention to content, quality, accuracy, and format.
– Collaborate with members of the R&D, Quality Control, Production, and Marketing teams to address various registration-related matters.

*Requirements:

– Minimum two years experience as Export Regulatory Specialist in Well established Pharmaceutical company with successful record in export business.
Interested candidate can send his/her C.V on:
Career@alandalous.org
Kindly mention the job title in the Subject,
Good luck.