
Methma Wattegedara
@methmawattegedara
Pharmacist and Regulatory Affairs Specialist, leading regulatory submissions and product lifecycle management.
What I'm looking for
I’m a registered pharmacist with experience in pharmaceutical regulatory affairs and quality assurance, and I’m independently developing my knowledge of international regulations, particularly in USA , Europe and ASEAN requirements.
In my current role, I lead regulatory submissions for new registrations, renewals, variations, and product lifecycle management, ensuring compliance with NMRA requirements. I also review product labeling and packaging materials and coordinate with authorities, manufacturers, and internal teams.
Previously, as a Quality Assurance Officer, I prepared stability study protocols and coordinated studies with the QC department.
Experience
Work history, roles, and key accomplishments
Senior Executive - Regulatory Affairs
Kelun Lifesciences Pvt Ltd
Apr 2026 - Present (6 months)
Lead regulatory submissions for new registrations, renewals, variations, and product lifecycle management, ensuring compliance with NMRA requirements. Develop and execute regulatory strategies to support timely product approvals and successful market launches.
Executive - Regulatory Affairs
Kelun Lifesciences Pvt Ltd
Jun 2023 - Present (3 years 4 months)
Managed end-to-end regulatory activities for medicines and medical devices, including dossier preparation, review, submission, and product registration. Led regulatory lifecycle management activities and supported regulatory inspections and audits.
Pharmacist Trainee
Sri Lanka Pharmacy Pvt Ltd
Nov 2022 - Apr 2023 (5 months)
Dispensed prescription and over-the-counter medicines, provided patient counselling, and managed pharmacy inventory. Ensured compliance of pharmacy records and SOPs with local regulations.
Quality Assurance Officer
Kelun Lifesciences Pvt Ltd
Mar 2021 - Oct 2022 (1 year 7 months)
Reviewed SOPs, protocols, reports, and specifications for product registration, and prepared stability study protocols. Improved internal document management and provided backroom assistance for NMRA inspections and ISO audits.
Education
Degrees, certifications, and relevant coursework
Sri Lanka Institute of Information Technology
MBA, Business Administration
2024 - 2025
Grade: Merit
Pursued an MBA with a focus on Business Administration, project management, and supply chain management. Research project on the impact of regulatory awareness and support on health product innovation in Sri Lankan universities.
Coursera
Brand Management: Aligning Business and Behavior, Brand Management
Completed the Brand Management: Aligning Business and Behavior course.
Mahamaya Girls' College
GCE A/L, Science
Completed GCE O/L and GCE A/L with a focus on Biology, Chemistry, and Physics.
Stanford University
Writing in Sciences, Writing
Completed the Writing in Sciences course on Coursera.
International Business Management Institute
Basics of Innovation Management, Innovation Management
Completed the Basics of Innovation Management certification.
General Sir John Kotelawala Defence University
Bachelor of Pharmacy (Hons), Pharmacy and Pharmaceutical Sciences
Grade: GPA 3.34 (Second class upper division)
Earned a Bachelor of Pharmacy (Hons) with a GPA of 3.34 (Second class upper division). Research project compared package inserts of parenteral products with innovators' SmPC.
SLAAS and MRI
Workshop on Toxicity Assessments, Toxicity Assessment
Attended a workshop on Toxicity Assessments.
Google Digital Garage
The Fundamentals of Digital Marketing, Digital Marketing
Completed The Fundamentals of Digital Marketing certification.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Salary expectations
Social media
Job categories
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