Lahiru Dilshan
@lahirudilshan
Regulatory and Quality Assurance leader driving compliance and quality in pharmaceuticals.
What I'm looking for
I am a seasoned Regulatory Affairs and Quality Assurance professional with extensive experience across regulatory submissions, QMS implementation, pharmacovigilance, and tender management in the pharmaceutical sector.
I have led regulatory and compliance functions, coordinated with authorities such as NMRA, SLSI, MOH and Food Control Authority, and prepared accurate regulatory dossiers to achieve timely product registrations and audit readiness.
In quality roles I have implemented ISO 9001:2015, led Good Distribution and Storage Practices initiatives, conducted audits and inspections, executed CAPA, and delivered distributor and warehouse improvements.
I drive cross-functional collaboration, develop SOPs and guidance documents, train teams in pharmacovigilance and QA processes, and lead tender participation—focused on sustaining regulatory compliance and organizational excellence.
Experience
Work history, roles, and key accomplishments
Manager - Regulatory Affairs
Laugfs Life Sciences (Pvt) Ltd
Aug 2025 - Present (4 months)
Lead the Regulatory Affairs Division, coordinating with NMRA, SLSI, MOH and other authorities to prepare compliant dossiers and ensure audit readiness while improving regulatory processes.
Manager - Regulatory, Quality Assurance & Compliance
Muller & Phipps (Health Care) Limited
Jun 2023 - Aug 2025 (2 years 2 months)
Led Regulatory & Compliance and Quality Assurance functions, implemented QMS achieving ISO 9001:2015, managed audits and distributor inspections, and ensured timely product registrations.
Regulatory Affairs Executive
Hemas Pharmaceuticals (Pvt) Ltd
Jan 2022 - Dec 2023 (1 year 11 months)
Managed regulatory matters and follow-ups for major manufacturers and coordinated submissions for over 200 companies to maintain product compliance.
Regulatory Affairs Junior Executive
A. Baur & Co. (Pvt.) Ltd.
Jan 2019 - Jan 2022 (3 years)
Handled regulatory registrations for medicines, medical devices, cosmetics, ayurvedic products and food, supporting compliance and market entry activities.
Education
Degrees, certifications, and relevant coursework
University of Sri Jayewardenepura
Bachelor of Pharmacy, Pharmacy and Pharmaceutical Sciences
Grade: 3.2 GPA
Graduated with a Bachelor of Pharmacy and Pharmaceutical Sciences in December 2019 with a 3.2 GPA.
Deniyaya Central College
G.C.E. Ordinary Level, Secondary Education (O-Level)
Grade: 9 A Passes
Completed G.C.E. Ordinary Level with 9 A passes.
Royal College, Colombo 07
G.C.E. Advanced Level, Pre-university (A-Level)
Grade: 3 B Passes
Completed G.C.E. Advanced Level with 3 B passes.
Availability
Location
Authorized to work in
Job categories
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