Summary
Overview
Work History
Education
Skills
Accomplishments
Publications (5-most recent)
Timeline
Generic
Priyanga Dharmaratne

Priyanga Dharmaratne

Tallinn

Summary

Highly accomplished professional with a Ph.D. in Medicinal Chemistry and extensive experience in the pharmaceutical industry. Proficient in navigating EU regulatory requirements, safety standards, and compliance protocols to ensure product safety and regulatory adherence. Demonstrated ability to quickly adapt and excel in fast-paced environments, fostering teamwork and driving results. Adept in pharmacovigilance and regulatory affairs, poised to make a substantial impact in the advancement of healthcare solutions.

Overview

15
15
years of professional experience

Work History

Regulatory Affairs Specialist and QPPV

Interchemie Werken De Adelaar Eesti AS
Tallinn
05.2023 - Current
  • Led compilation, review, and submission of regulatory dossiers for veterinary product approvals within the EU market
  • Conducted technical writing for the preparation of dossiers, including Quality, Safety, and Efficacy sections
  • Coordinated with internal and external stakeholders to streamline dossier submission and approval processes
  • Oversaw post-marketing commitment studies to ensure compliance with regulatory requirements.
  • Prepared and submitted variation dossiers (VRA and VNRA) for updating product information as necessary
  • Monitored and managed regulatory activities throughout the product lifecycle
  • Analyzed and decoded generic product recipes for product development
  • Planned and executed analysis of physiochemical properties of reference products
  • Ensured bioequivalence through comprehensive studies and assessments

Research Associate

The Chinese University of Hong Kong
Hong Kong
08.2017 - 08.2023
  • Developed and executed In vitro antimicrobial photodynamic inactivation (aPDI) studies for a novel photosensitizer
  • Induced MRSA-infected wounds in a mouse model and conducted In vivo studies to investigate aPDI efficacy
  • Formulated thermo-sensitive Methylene Blue hydrogels for use as wound dressings in photodynamic therapy for combating bacteria-infected wounds

Visiting Lecturer

Horizon Campus
Malabe
01.2016 - 06.2017
  • Visiting Lecturer and conducted General Chemistry, Organic Chemistry and Drug and Pharmaceutical Technology lectures for the undergraduate students from Nilai University, Malaysia and Arkansas State University, USA

Lecturer

South Asian Institute of Technology and Management
Malabe
01.2012 - 06.2014
  • Conduct small group lectures and practical lessons for the General Chemistry, Organic Chemistry and for the Biochemistry subjects

Dipping Chemist

Smart Shirts Limited
Katunayake
10.2010 - 12.2011
  • The first dipping plant in SL to optimize 100% Colton shirts with wrinkle free quality
  • I have involved in optimizing formulas to enhance product quality during bulk manufacturing

Teaching Assistant

Institute of Chemistry Ceylon, Sri Lanka
Colombo
09.2009 - 09.2010

Education

Ph.D. - Medicinal Chemistry

University of Peradeniya
Sri Lanka
12.2017

Chemistry -

Institute of Chemistry Ceylon, College of Chemical Sciences
Sri Lanka
12.2009

High school or equivalent -

St Johns College
Nugegoda, Sri Lanka
12.2004

Skills

  • Regulatory Agency Applications
  • Audits
  • Document Control
  • Validation Protocols
  • Risk Management
  • Product Information
  • Regulatory Policies
  • Project Management
  • Technical Documentation
  • Labeling requirements

Accomplishments

  • Completed training in Good Manufacturing Practice (GMP) and GxP standards
  • Successfully completed Pharmacovigilance 3 - Pv Audit training through White Hall
  • Completed Pharmacovigilance 2 training on Global Regulatory Requirements through White Hall

Publications (5-most recent)

Yang L, Dharmaratne P, Zhu C, Sapugahawatte DN, Rahman N, Barua N, Li C, Kin On Kwok, Luo M, Liyanapathirana V, Ip M. Global epidemiology of asymptomatic colonization of methicillin-resistant Staphylococcus aureus in the upper respiratory tract of young children: a systematic review and meta-analysis. Archives of Disease in Childhood. 2024. 10.1136/archdischild-2023-326124.

Rita WY Ng, Dharmaratne P, Wong S, Hawkey P, Chan PC, Ip M. Revisiting the donor screening protocol of fecal microbiota transplantation (FMT): a systematic review. Gut. 2023; doi: 10.1136/gutjnl-2023-329515

BCL Chan+, Dharmaratne P+, Wang B, KM Lau, CC Lee, DWS Cheung, JYW Chan, GGL Yue, CBS Lau, CK Wong, KP Fung, M Ip. Hypericin and Pheophorbide a Mediated Photodynamic Therapy Fighting MRSA Wound Infections: A Translational Study from In Vitro to In Vivo. Pharmaceutics, 2021, 13, 1399.

Dharmaratne P, Rahman N, Leung A, Ip M. Is there a role of fecal microbiota transplantation in reducing antibiotic resistance burden in gut? A systematic review and meta-analysis. Annals of Medicine. 2021, 53, 661-682

Dharmaratne P, Ligang Yu., Wong, RC, Chan BCL, Lau KM, Clara BS Lau CBS , Ng DKP , Fung KP, Ip M. A Novel Dicationic Boron Dipyrromethene-based photosensitizer for antimicrobial photodynamic therapy against methicillin-resistant Staphylococcus aureus: An In vitro and In vivo study. Current Medicinal Chemistry, 2021, 28, 1-12

Dharmaratne P, Wanga B, Wong RC, Chan BCL , Lau KM , Clara BS Lau CBS , Ng DKP , Fung KP, Ip M. Monosubstituted tricationic Zn(II) phthalocyanine enhances antimicrobial photodynamic inactivation (aPDI) of methicillin-resistant Staphylococcus aureus (MRSA) and cytotoxicity evaluation for topical applications: in vitro and in vivo study. Emerging Microbes and Infections. 2020, 9: 1628-1636.

Timeline

Regulatory Affairs Specialist and QPPV

Interchemie Werken De Adelaar Eesti AS
05.2023 - Current

Research Associate

The Chinese University of Hong Kong
08.2017 - 08.2023

Visiting Lecturer

Horizon Campus
01.2016 - 06.2017

Lecturer

South Asian Institute of Technology and Management
01.2012 - 06.2014

Dipping Chemist

Smart Shirts Limited
10.2010 - 12.2011

Teaching Assistant

Institute of Chemistry Ceylon, Sri Lanka
09.2009 - 09.2010

Ph.D. - Medicinal Chemistry

University of Peradeniya

Chemistry -

Institute of Chemistry Ceylon, College of Chemical Sciences

High school or equivalent -

St Johns College
Priyanga Dharmaratne