Job Description

Company overview:
Vieco Pharmaceuticals is a pharmaceutical factory in JAFZA Dubai for the production of solid (Tablets and Capsules), Liquid (Syrups) and semi-solid (Ointment and Creams) pharmaceutical products.

Job responsibilities
The Regulatory affairs professional will be responsible for the preparation of the dossier in compliance with the ICH, EMA, UAE and SFDA regulatory requirements.
o Regulatory compliance & submissions: Prepare and submit regulatory dossiers, variations, and renewals for non-sterile dosage forms.
o CTD dossier compilation: Prepare all the modules (M1-M5) of the dossier in CTD format as per the regulatory requirements of ICH, EMA, UAE, and SFDA.
o eCTD publishing: Prepare & Publish the CTD dossier in eCTD format.
o Labelling and documentation: Ensure that the product labelling and packaging materials comply with the UAE and International regulations.
o Cross-functional collaboration: Work closely with QA, QC, Production and Supply chain teams to align regulatory requirements with operational goals.
o Preparation and review of Artworks information.
o Must have experience with Ample Logic software.
o Experience in submitting the product registration files for the UAE, Saudi Arabia and Europe regulatory authorities’ registration.
o Good knowledge and Experience in implementing the ICH, EMA and SFDA regulations.
o Maintenance of the regulatory database up to date.

Other requirements
o Must have 3 to 5 years of experience in regulatory affairs within the pharmaceutical industry in the UAE.
o Good communication and project management skills.