Abdel

Regulatory Affairs Assistant Pharmacist

SARL Biopharm - ALGERIA • Tiempo completo

Oct 2023 - Present • 3 yrs 1 mo

Supports regulatory affairs activities to ensure pharmaceutical products meet legal, quality, and safety standards throughout their lifecycle. My job includes : - Assist in preparing and updating regulatory dossiers and submissions. - Support compliance with FDA and international regulatory requirements. - Review product labeling, packaging, and promotional materials for regulatory accuracy. - Track regulatory changes and help implement updates accordingly. - Coordinate with internal departments (QA, R&D, Manufacturing, Marketing). - Maintain regulatory documentation and ensure proper archiving. - Assist in responses to regulatory authority queries and inspections. - Support product registration, renewals, and variations. - Help ensure pharmacovigilance and post-marketing compliance activities.