Sakthikumar Ragupathy

Regulatory Affairs professional acting as Product Regulatory Lead for global biosimilar programs, with strong experience in cross-functional coordination, submissions, and regulatory strategy execution. I actively participated in lead dossier preparation activities, Marketing Authorization Applications, variation submissions, CTA submissions, Labelling activities. Throughout my career in the pharmaceutical industry, I have developed an analytical mindset and a keen attention to detail, complemented by strong planning skills and a proactive attitude.

Fast learner, self-motivated and self-organized, I am enthusiastic about working as part of a team and growing professionally and personally. Skilled in various domains including Advanced drug delivery systems, Biopharmaceutics, CMC (Chemistry Manufacturing and Controls), Analytical Method development, biologics (including biosimilars) and gene Therapy.

Completed

Certification in Medical Device Regulatory Affairs Professional Programme. My goal is to continuously build upon my skills in the field of Regulatory affairs with commitment to excellence.

• 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