Regulatory Affairs Executive – Pharma (Sri Lanka)

About the role

We are looking for a detail‑oriented Regulatory Affairs Executive to manage pharmaceutical product registrations, renewals, import licences and the full product lifecycle in Sri Lanka. The role involves close interaction with the National Medicines Regulatory Authority (NMRA) and internal teams to ensure compliance and uninterrupted market access.

Key responsibilities

• Prepare and submit registration and renewal applications to the NMRA.
• Manage sample licence applications and follow up for timely approvals.
• Collect, review and file evaluation documents, post‑approval compliance requirements and renewal paperwork.
• Prepare import licence documentation, maintain licence validity and coordinate renewals.
• Maintain accurate product lifecycle records and ensure shipment images meet regulatory standards.
• Compile Certificates of Analysis and related product documentation for shipments.
• Support tender and bidding processes by preparing required documents and product images.
• Coordinate new product inclusions, updates and trademark filings with the relevant authorities.
• Handle payments for NMRA fees, third‑party testing and other regulatory costs.

Required profile

• Pharmacy graduate with a valid licence.
• Minimum 3 years of experience in the pharmaceutical industry.
• Good knowledge of product registration, renewal and import licence processes.
• Familiarity with NMRA procedures and documentation requirements.
• Ability to coordinate with regulators, suppliers and internal teams.

Required skills