selvaraj vinosha
@selvarajvinosha
Experienced regulatory officer with expertise in compliance and quality assurance.
What I'm looking for
I am a registered and licensed pharmacist in Sri Lanka since 2015, specializing in regulatory affairs and pharmacovigilance. My extensive experience includes managing the complete product registration process for renowned brands such as COTY, Shiseido, and Dolce & Gabbana. I ensure compliance with the National Medicines Regulation Authority (NMRA) standards and European Commission regulations, demonstrating my commitment to quality and safety in the pharmaceutical and cosmetic industries.
Throughout my career, I have effectively collaborated with marketing and supply chain teams to streamline regulatory processes and facilitate timely product launches. My role involves representing my company during regulatory authority visits and providing comprehensive operational reports to management. I have a proven track record of handling registrations for various international products, ensuring adherence to local and international regulatory standards.
With a strong foundation in regulatory affairs, I am dedicated to continuous learning and professional development. I hold certifications in European Medical Device Regulations and have participated in various training programs to enhance my knowledge in Good Manufacturing Practices and regulatory compliance. I am passionate about contributing to the healthcare sector and ensuring that safe and effective products reach consumers.
Experience
Work history, roles, and key accomplishments
Regulatory Officer
Luxasia S L (Pvt) Ltd
Oct 2019 - Present (5 years 8 months)
Managed the complete product registration process for international brands like COTY, Shiseido, Dolce & Gabbana, Creed, and Olaplex in Sri Lanka, ensuring compliance with NMRA standards. Represented the company in regulatory authority visits and communicated with partner brands to streamline regulatory processes.
Executive Manager
Premier Healthcare (Pvt) Ltd
Apr 2012 - Aug 2019 (7 years 4 months)
Managed daily operations in Regulatory Affairs, focusing on the preparation and evaluation of documents for regulatory authority submission. Handled registrations for products from Medcomp-USA, Nipro-Japan and Lotus-India ensuring compliance with National Medicines Authority of Sri Lanka standards.
Regulatory Officer
Radiant Healthcare (Pvt) Ltd
Oct 2010 - Mar 2012 (1 year 5 months)
Evaluated technical information for generic products from French pharmacopoeia submissions by manufacturers/distributors and provided recommendations for registration eligibility. Handled follow-ups on product applications and responded to inquiries.
Education
Degrees, certifications, and relevant coursework
Oxford Brookes University
Bachelor of Science (Hons), Biomedical Science
Completed a Bachelor of Science with Honours in Biomedical Science. The program provided a comprehensive understanding of biological and medical sciences.
Institute of Chemistry Ceylon
Diploma, Laboratory Technology in Chemistry
Obtained a Diploma in Laboratory Technology with a specialization in Chemistry. The curriculum covered practical skills and theoretical knowledge essential for laboratory operations.
Asia e University
Executive Master's, Health Administration
Pursued an Executive Master's in Health Administration. This program focused on leadership and management principles within the healthcare sector.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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