Drug Regulatory Affairs Specialist

About the role

The Drug Regulatory Affairs Specialist will support the implementation of regulatory strategies for Pharmaline’s portfolio, ensuring timely marketing authorizations, approvals and lifecycle management of products in both local and export markets while maintaining compliance with all regulatory requirements.

Key responsibilities

• Ensure Pharmaline products meet registration, pricing and reimbursement regulations in target markets.
• Prepare and submit CTD dossiers, new registrations, variations, renewals and repricing applications.
• Conduct daily visits to the Ministry of Public Health to follow up on submissions and approvals.
• Coordinate artwork review with manufacturing to guarantee regulatory and quality compliance.
• Maintain documentation systems for all regulatory activities and support audit readiness.
• Manage regulatory liaison with authorities, ministries, and principal companies.
• Support pharmacovigilance operations, including case coordination, literature screening and safety reporting.
• Assist supply‑chain processes such as invoice legalization and customs declarations when required.
• Collaborate with legal to register trademarks and monitor updates to national and international regulatory guidelines.

Required profile

• Proven experience in pharmaceutical regulatory affairs covering local and export markets.
• Familiarity with Ministry of Public Health procedures and reimbursement institutions.
• Ability to interact effectively with regulatory authorities, legal teams and manufacturing units.
• Attention to detail in documentation and compliance activities.

Required skills

• CTD dossier preparation and submission.
• Regulatory submission management for registrations, variations and renewals.
• Pharmacovigilance operational support (case processing, literature screening, safety reporting).
• Artwork review coordination with manufacturing.
• Trademark registration coordination.