Manager – Regulatory Affairs

We are seeking a dynamic and detail oriented regulatory affairs manager to oversee our regulatory compliance and submissions function in line with NMRA requirements.

Key responsibilities

1. Prepare, review, and submit regulatory dossiers (CTD format) for new medicines and medical devices, including renewals and re-registrations.
2. Ensure all company products comply with National Medicines Regulatory Authority (NMRA) regulations and applicable international guidelines.
3. Manage dossier review and evaluation for accuracy, completeness and compliance.
4. Coordinate all NMRA submissions, follow-ups and additional document requirements.
5. Handle transport license applications, manufacturing site registrations, and variation submissions.
6. Liaise with NMRA departments and relevant stakeholders for approvals, inspections, and regulatory updates.
7. Oversee regulatory inspections related to storage and compliance audits.
8. Monitor tender documentation and regulatory timelines, including pending regulatory payments.
9. Provide strategic regulatory guidance to senior management for new product introductions.
10. Maintain monthly regulatory reporting and communication with principals and partners.
11. Support negotiation and follow-up for marketing authorizations (SPC/hospitals).

Mandatory requirements

1. Bachelor’s degree in pharmacy or related field.
2. Valid professional license where applicable (pharmacist registration with Sri Lanka Medical Council).
3. Minimum relevant experience (3-5 years) in regulatory affairs or pharmaceutical compliance.
4. Strong knowledge of NMRA regulatory procedures and CTD dossier preparation.
5. Strong attention to detail with ability to manage multiple deadlines.
6. Excellent communication and stakeholder coordination skills.

About the company

We are a leading pharmaceutical company based in Kalubowila.

When applying

Send us your CV!