Regulatory Manager

Regulatory ManagerRasan Pharmaceutical seeks an experienced Regulatory Manager to lead regulatory affairs activities and ensure full compliance with pharmaceutical regulations. The successful candidate will manage product registrations, regulatory submissions, and relationships with health authorities to support business growth and operational excellence.Key Responsibilities:Lead regulatory strategies and maintain relationships with the Ministry of Health and other regulatory authorities.Manage product registrations, re-registrations, and market authorization renewals.Ensure compliance with local regulations, GMP standards, and company policies.Oversee regulatory submissions, inspections, sampling, and product release processes.Monitor regulatory changes and provide timely regulatory intelligence to management.Prepare and maintain product dossiers, labeling, leaflets, and other regulatory documentation.Support production planning and cross-functional projects by providing regulatory expertise.Manage regulatory databases, records, and reporting while ensuring timely completion of all regulatory activities.Requirements:Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or Chemistry.5+ years of experience in the pharmaceutical industry, preferably with sterile/injectable products.Strong knowledge of pharmaceutical regulations, product registration processes, and GMP requirements.Experience dealing with health authorities and managing regulatory submissions and inspections.Excellent communication, stakeholder management, and reporting skills.Strong planning, organizational, and problem-solving abilities.