Kalaiyarasan Ramasamy
Regulatory Affairs Associate @Navitas Life Sciences
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WORK HISTORY
Regulatory Affairs Associate @Navitas Life Sciences
Chennai, IN
CMC Authoring for US / EU / Canada with applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliancePreparing CMC response to health authority questions during development, registration and product lifecycle
EDUCATION
Karpagam Academy of Higher Education, Coimbatore
Bachelor of Pharmacy
JSS College of Pharmacy, Ooty
Associate of Pharmacy
Karpagam Academy of Higher Education
Bachelor of Pharmacy - pharmacovigilance and cosmetic science
JSS College of Pharmacy, Ooty - "Ootacamund"
Diploma in pharmacy
Kongunadu Matric Hr Sec School, VGP
HSC , Bio-Math
ABOUT KALAIYARASAN RAMASAMY
Regulatory Affairs professional with 3.6 years of experience in CMC dossier preparation, submission, and management of CTD/eCTD dossiers. Skilled in handling variations, renewals, and regulatory query responses, proven ability to handle cross-functionally and ensure compliance with health authority requirements including US/EU/Canada and ROW markets.
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