Sakthikumar Ragupathy

- PROFESSIONAL EXPERIENCE ---------------------- 
REGULATORY AFFAIRS SPECIALIST, Fresenius Kabi SwissBioSim GmbH 
Nyon, Switzerland           
2025 
July 2023 – Sept 
● Regulatory Affairs Lead, responsible for EU, Canada, UK, CH, Serbia for the Ustekinumab Biosimilar product 
● Preparation and submission of variations and other Life Cycle Management activities. 
● Facilitated Marketing Authorization Applications, including BLA supplemental filing in the USA and MAA filings in 
the EU through EMA centralized procedure and for RoW countries.  
● Led CTA submission (new CTIS platform) for a Phase II clinical trial supporting autoinjector device development. 
● Actively contributed to regulatory planning and submission strategy across global markets. 
● Prepared Module 1 documentation (e.g., cover letters, responses to deficiencies) and managed labelling 
components such as IFUs, QRGs, and carton/blister labels. 
● Managed labelling activities including for a Combination product (On-body injector device). 
● Represented Regulatory Affairs in cross-functional teams to align regulatory input with clinical, quality, and 
commercial objectives. 
● Effectively communicated with stakeholders, facilitated interactions, and provided information to local affiliates in 
response to health authorities.  
● Coordinated with internal subject matter experts to ensure high-quality, compliant regulatory submissions. 
● Supported pharmacovigilance activities, including update reports and archive management. 
● Reviewed promotional and advertising materials to ensure alignment with regulatory standards. 
ANALYTICAL FORMULATION SCIENCES (CONTRACTOR), KBI Biopharma SA   
Geneva, Switzerland                         
● Conducted Bioanalytical Assays such as ELISAs, QPCR, and HPLC. 
● Ensured regulatory compliance through GMP and QA collaboration. 
● Worked on monoclonal antibody formulation in a CDMO setting. 
Feb 2022 – June 2023 
CERTIFICATE OF ADVANCED STUDIES IN REGULATORY AFFAIRS PHARMA, Bern University  
Bern, Switzerland                         
Sept 2021 – April 2022 
● Achieved 12 ECTS credits; excelled in the exam (87%) and project work (90%). 
POST-DOCTORAL FELLOW IN BIOPHARMACEUTICAL SCIENCES, University of Geneva 
Geneva, Switzerland                          
April 2019 – Dec 2021 
● Led macromolecular drug delivery projects. 
● Managed research timelines and team collaboration. 
DEPUTY PRINCIPAL INVESTIGATOR – EU CONSORTIUM PROJECT, University of Santiago Compostela 
Santiago Compostela, Spain                                        
● Conducted Led RNA-based nanomedicine projects for neurological diseases. 
● Developed innovative RNA delivery systems. 
SCIENTIST & TEACHING ASSISTANT, University of Geneva 
Geneva, Switzerland                             
. 
● Macromolecular delivery of drugs across biological barriers of the body. 
● Management and design of the research projects within the stipulated timelines. 
● Supervised lab sessions for Bachelor and Master students. 

PhD in Biopharmaceutical Sciences, University of Geneva, Geneva, SWITZERLAND 
MSc in Molecular Medical Biology, Orebro University, Orebro, SWEDEN 
Bachelors in Pharmacy, The Tamil Nadu Dr. M.G.R Medical University, Chennai, INDIA