Drug Regulatory Affairs Specialist

About the role

Malia Group is looking for a Drug Regulatory Affairs Specialist to support the implementation of regulatory strategies and plans for its portfolio and licensed products, locally and in export markets. The role ensures timely marketing authorizations, approvals and lifecycle management while guaranteeing compliance with regulatory requirements, in line with Malia Group policies and procedures.

Key responsibilities

• Ensure products comply with registration, pricing and reimbursement regulations in local and export markets.
• Manage the regulatory portfolio, including preparing and submitting CTD dossiers, new registrations, variations, renewals, repricing and lifecycle management submissions.
• Follow up daily on regulatory submissions, applications and approvals with the Ministry of Public Health (MoPH).
• Prepare registration and repricing applications and coordinate artwork reviews with the manufacturing team.
• Maintain documentation systems, support compliance readiness for inspections and audits, and liaise with regulatory authorities and ministries.
• Coordinate regulatory affairs for the manufacturing site, including inspections and certificate issuance.
• Support reimbursement applications and product introductions to hospitals and healthcare institutions, and help with invoice legalization, customs declarations and inspections when needed.
• Work with the legal department on trademark registration and share regulatory knowledge across departments.
• Support pharmacovigilance activities: case processing, literature screening, safety reporting, PSUR preparation and compliance with reporting timelines.
• Provide regulatory intelligence to Marketing and collaborate with R&D, Marketing and Sales.

Required profile

• Bachelor's degree in Pharmacy; Pharm D is a plus.
• At least 2 years of previous related experience.
• Experience in pharmacovigilance activities is a must.