Drug Regulatory Affairs Specialist

Job PurposeResponsible for supporting the implementation of regulatory strategies and plans for Pharmaline's portfolio and licensed products locally and in export markets.Responsible for ensuring timely marketing authorization, approvals and lifecycle management of products in local and export markets, while guaranteeing compliance with regulatory requirements. Perform duties in accordance with Malia Group Policies and Procedures.Duties And ResponsibilitiesOn Regulatory AffairsEnsure Pharmaline products comply with registration, pricing, and reimbursement regulations in local and export markets.Manage Pharmaline’s and licensors’ regulatory portfolio including preparation and submission of CTD dossiers, new registrations, variations, renewals, repricing, and lifecycle management submissions in local and export markets.Conduct daily visits to the Ministry of Public Health (MoPH) to follow up on regulatory submissions, applications and approvals.Prepare registration and repricing applications for Pharmaline and licensed pharmaceutical and para-pharmaceutical products for local and export markets.Ensure all regulatory aspects of applications submitted to Ministries, reimbursement institutions, governmental and non-governmental entities, Orders of Pharmacists, and Orders of Physicians are completed within the required timeframe.Coordinate artwork review for Pharmaline's portfolio in collaboration with the manufacturing team, ensuring compliance with regulations and quality standards.Maintain proper documentation systems for all Regulatory Affairs activities and submissions.Support regulatory compliance readiness and assist in preparation for regulatory inspections and audits.Coordinate Regulatory Affairs matters related to the manufacturing site; organize and follow up on local, foreign, public and private regulatory inspections and related certificates issuance for the site in coordination with concerned departments.Maintain effective relationships with regulatory authorities, ministries, institutions, and principals to ensure efficient execution and follow-up of regulatory activities.Ensure a high standard of service with the regulatory liaison of the Principals.Support regulatory applications related to product reimbursement and introduction of products into hospitals and other healthcare institutions as needed.Support supply chain activities such as invoice legalization, customs declarations and inspection process when needed.Coordinate with the legal department for the trademarks registration at the Ministry of Economy & Trade.Monitor and stay up to date with national and international regulatory guidelines, requirements and best practicesOn Pharmacovigilance SupportSupport pharmacovigilance operational activities under Regulatory Affairs supervision, including case processing coordination, literature screening, safety reporting and compliance.Coordinate pharmacovigilance activities with external service providers when requiredAssist in literature screening and safety information monitoring.Contribute to the preparation and submission of Periodic Safety Update Reports (PSURs).Ensure compliance with pharmacovigilance reporting timelines and requirements.On Interdepartmental TasksShare with the Marketing team regulatory intelligence feedback including competitor and market regulatory information.Control shipping documents of goods prior to their submission to the Ministry of Public Health (MoPH) in coordination with the procurement department and follow up when needed.Generate and share with concerned departments, knowledge on local and international pharmaceutical regulations (Registration, pricing, patent..).Collaborate proactively with the R&D, Marketing and Sales departments to ensure smooth and timely execution of approved plans.EducationBachelor's Degree in Pharmacy. Pharm D is a plus. ExperienceMinimum 2 years of previous related experience.Experience in Pharmacovigilance activities is a must.Apply now at www.joinmalia.com, or send your CV to hr@joinmalia.com and mention the position title in the subject line.