Job description

Job Purpose • Responsible 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 Responsibilities On Regulatory Affairs
• Ensure 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 practices
On Pharmacovigilance Support
• Support 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 required.
• Assist 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 Tasks
• Share 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.