Requirements
Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field.4–7 years of experience in Regulatory Affairs within the pharmaceutical industry.Strong knowledge of pharmaceutical registration requirements and regulatory guidelines.Experience in dossier preparation, variations, renewals, and regulatory submissions.Strong communication, coordination, analytical, and problem-solving skills.Good command of English / French and proficiency in Microsoft Office.
Description
Prepare, review, and submit regulatory dossiers, variations, renewals, and registration documents.Coordinate with regulatory authorities and respond to queries and requests for additional information.Ensure regulatory compliance throughout the product lifecycle.Review and assess changes related to manufacturing, formulation, specifications, labeling, and packaging for regulatory impact.Maintain regulatory databases, records, and product licenses.Coordinate with R&D, QA, QC, Manufacturing, and other functions to ensure timely regulatory submissions.Monitor regulatory guidelines and assess their impact on the company's products and processes.Support regulatory inspections and ensure timely closure of regulatory commitments.