Job Description
Avennier Pharma (Private) Limited
We are, a leading pharmaceutical company based in Kalubowila on the lookout for a 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:
- Prepare, review, and submit regulatory dossiers (CTD format) for new medicines and medical devices, including renewals and re-registrations
- Ensure all company products comply with National Medicines Regulatory Authority (NMRA) regulations and applicable international guidelines
- Manage dossier review and evaluation for accuracy, completeness and compliance
- Coordinate all NMRA submissions, follow-ups and additional document requirements
- Handle transport license applications, manufacturing site registrations, and variation submissions
- Liaise with NMRA departments and relevant stakeholders for approvals, inspections, and regulatory updates
- Oversee regulatory inspections related to storage and compliance audits
- Monitor tender documentation and regulatory timelines, including pending regulatory payments
- Provide strategic regulatory guidance to senior management for new product introductions
- Maintain monthly regulatory reporting and communication with principals and partners
- Support negotiation and follow-up for marketing authorizations (SPC/Hospitals)
Mandatory Requirements:
- Bachelor's degree in Pharmacy or related field
- Valid professional license where applicable (Pharmacist registration with Sri Lanka Medical Council)
- Minimum relevant experience (3-5 years) in regulatory affairs or pharmaceutical compliance
- Strong knowledge of NMRA regulatory procedures and CTD dossier preparation
- Strong attention to detail with ability to manage multiple deadlines
- Excellent communication and stakeholder coordination skills
Send us your CV! hrdept@avenierpharma.com