WE ARE HIRING: Regulatory Affairs Executive

Location: Sri Lanka
Employment Type: Full time
Industry: Pharmaceutical / Healthcare / Regulatory Affairs

Role Overview

We are seeking a detail-oriented and self-driven Regulatory Affairs Executive to manage pharmaceutical product registration, renewals, import licence documentation, dossier coordination, regulatory submissions, and product lifecycle maintenance in Sri Lanka.

The selected candidate will be responsible for coordinating with regulatory authorities, product suppliers, marketing, logistics, finance, and administration teams to ensure timely compliance with NMRA requirements, documentation standards, and post-approval obligations.

Key Responsibilities

• Support pharmaceutical product registration and renewal processes with the relevant regulatory authorities.
• Review initial registration compliance requirements and prepare applications for submission to NMRA.
• Prepare, compile, and submit documentation for new product registrations, renewals, variations, and post-approval changes.
• Manage sample licence applications and follow up to obtain approvals within required timelines.
• Collect, review, and check evaluation documents, post-approval compliance requirements, special conditions, and renewal documents.
• Prepare final document compilations for variation applications.
• Prepare documentation required for import licence applications and shipment clearance.
• Maintain import licence validity and coordinate timely renewals to support uninterrupted shipment clearance.
• Maintain product lifecycle documentation and ensure records are accurate and updated.
• Coordinate with product suppliers to obtain compliance documents for dossier completion.
• Review and coordinate final product artwork for new product registration and commercial requirements.
• Check shipment images and ensure they meet regulatory and documentation requirements.
• Compile valid and updated Certificates of Analysis and related product documentation.
• Support marketing and logistics teams with regulatory information and documentation requirements.
• Support tender and bidding applications by preparing required documents and product images.
• Coordinate submissions for new product inclusions and updated product information.
• Support trademark application filing and follow-up with the relevant intellectual property office.
• Request and coordinate payments for NMRA fees, third-party testing laboratory fees, and other regulatory payments.
• Prepare day-to-day regulatory affairs reports for management review.
• Maintain working folders, file records, backups, and proper documentation systems.
• Ensure all regulatory documentation is complete, traceable, and audit-ready.
• Work independently while coordinating effectively with internal and external stakeholders.
• Perform any other regulatory affairs, documentation, or compliance-related duties assigned by management.

Candidate Profile

• Pharmacy graduate with a valid licence is required.
• Minimum 3 years of work experience in a pharmaceutical industry environment.
• Good working knowledge of pharmaceutical product registration and renewal processes.
• Experience handling NMRA submissions, renewals, variations, import licences, and regulatory documentation will be preferred.
• Existing contacts or working relationships with NMRA will be an advantage.
• Good understanding of regulatory documentation, dossiers, product lifecycle maintenance, and compliance requirements.
• Ability to coordinate with regulatory authorities, suppliers, internal teams, and external service providers.
• Strong documentation, filing, reporting, and record-management skills.
• Good attention to detail and ability to review documents accurately.
• Good English communication skills, both written and spoken.
• Flexible and self-driven work attitude.
• Ability to work with minimum supervision.
• Trustworthy, ethical, and able to handle confidential regulatory and product information.
• Strong follow-up skills with the ability to manage timelines and pending actions.
• Organized, responsible, and committed to maintaining regulatory compliance standards.

Ready to take your career to new heights?

We're InTalent Asia, your go-to recruitment partner in Sri Lanka, and we've got an exciting opportunity for you! Our client is looking for a dynamic individual to fill the role of Regulatory Affairs Executive.

At InTalent Asia, we're not just recruiters; we're here to architect your career success. Join us in the journey of matching your skills with unparalleled opportunities.

Apply now and see how you can be the perfect fit for this exclusive position!

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