• 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.

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.