Regulatory Affairs Specialist
Pranic Drug Store LLC, Dubai
About Safana Ali
I am Safana Ali, a Regulatory Affairs Pharmacist based in Dubai and licensed by the UAE Ministry of Health. My work covers product classification and registration for health supplements, conventional products, medical devices and GSL products. I prepare and review the dossier, make sure labeling and artwork meet requirements, obtain Dubai Drug Codes and HAAD codes, and clear shipments through DM and EDE import permits.
Most of it sits between the company and the health authority. I gather and organise information in whatever format the authority asks for, answer their queries, and keep the submission moving until the approval comes through. Alongside that I oversee warehouse storage so products stay compliant once they are in the country.
Regulatory affairs expertise
Registration and renewals
Pharmaceutical product registration, site registration, drug renewals, minor variations, MAH registration and DM registration.
Submissions and dossiers
Dossier review, plus eCTD preparation, evaluation and validation before filing.
Health authority coordination
DDC and HAAD code registration, direct correspondence with authorities, and cross functional follow up until a file closes.
Labeling and artwork
Artwork and patient information leaflets prepared and checked against MOH requirements.
Import permits and clearance
MOHAP import permits for medical devices and medical products, and DM import permits for shipment release.
Pharmacovigilance
Monitoring and reporting adverse events as a licensed pharmacovigilance officer.
Regulatory affairs experience
Regulatory Affairs and Pharmacovigilance Intern
Apotex Inc., Dubai
Regulatory Affairs Intern
MNB Company, Dubai
Pharmacist
Daya Medicals, Malappuram, Kerala
Education
Professional Regulatory Affairs, GCC
Dubai Pharmacy College, 2021
Bachelor of Pharmacy
Karuna College of Pharmacy, Kerala, 2014 to 2018
Licenses and certifications
MOH License
Ministry of Health and Prevention, United Arab Emirates
Pharmacovigilance Officer License
Authorised to monitor and report adverse events
UAE Driving License
Valid, own transport
Contact Safana Ali
Open to regulatory affairs roles in the UAE.
The best way to reach me is LinkedIn. Send a message there and I will get back to you.
Safana Ali, Regulatory Affairs Pharmacist, Dubai
United Arab Emirates