Regulatory Affairs Assistant

Description

Position Summary: We are seeking a Pharmaceutical Chemist to join our sales team, focused on the evaluation and registration of dossiers and the follow-up of pharmaceutical files. Key Highlights: 1. Part of a pharmaceutical sales team with over 11 years of service. 2. Conducts evaluation and registration of pharmaceutical product dossiers. 3. Communicates with manufacturers and manages observations submitted to DIGEMID. A pharmaceutical company with over 11 years of service is seeking talented professionals to join our pharmaceutical sales team, with strong motivation for professional growth. Requirements: Bachelor's degree in Pharmaceutical Chemistry At least 1 year of work experience in laboratories, pharmacies, or drugstores (MANDATORY) Experience and knowledge of VUCE Knowledge of pharmacopoeias Familiarity with Peruvian regulatory standards D.S. 016 and its amendments. Contact number: 955102094 Responsibilities: Evaluate and register dossiers for pharmaceutical product registration and re-registration processes. Raise observations before DIGEMID when necessary. Communicate with manufacturers regarding any observations issued by the regulatory authority. Demonstrable knowledge of current regulations and pharmacopoeias. Continuously monitor notices, alerts, and amendments to Supreme Decrees (D.S.) published by the authority via its virtual platform. Track pharmaceutical files. Translate technical documents. Consult with the Technical Department regarding dossier prioritization. Salary: S/.102.00 - S/.150.20 per month Application Question(s): * Which district do you currently live in? What is your date of birth? * How many years of experience do you have preparing pharmaceutical product dossiers? How many dossiers do you prepare per month? * Have you handled submission, registration, and subscription processes? Work Location: On-site employment