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.
Education
- Bachelor's Degree in Pharmacy. Pharm D is a plus.
Experience
- Minimum 2 years of previous related experience.
- Experience in Pharmacovigilance activities is a must.
Apply now at www.joinmalia.com, or send your CV to [email protected] and mention the position titlein the subject line.
