Regulatory Affairs Specialist

ago

Splendid Pharma

#Regulatory_Affairs_Specialist

Registration of new products.
Maintaining licenses of registered products.
Submitting variations of existing products.
Dealing with existing products and expanding company portfolio with new products including: pharmaceuticals.
Building up & submitting files to competent authority
Prepare analytical files to be submitted to different authorized labs
Follow up analysis and supply all needed requirement to get release certificates f samples.
Maintaining communication & following up with the competent authorities and internally
Maintain systems of regulatory work up to date
Support logistic team with all references , legalized certificates and material needed for regular analysis and release
Support MER with any needed support
Job Requirements
Max. 5 years experience in the same field
Deep experience in pharmaceutical industry from a regulatory affairs perspective
Knowledge of pharmaceutical legislation, relevant guidelines, procedures and requirements
Fluent in oral and written Arabic and English
IT skills
Pharmacist is a must
self motivated and dynamic

APPLY here