Kabilan Ramakrishnan
Regulatory Affairs officer -II at Medreich limited, Bangalore Ex-Softgel Healthcare Private Limited
- Role
- Regulatory Affairs Officer -ii at Medreich Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Kabilan Ramakrishnan
I have 1 + years of hands-on experience in the pharmaceutical regulatory domain, with comprehensive knowledge of the global regulatory framework. I’ve successfully managed multiple projects across various countries, focusing on the preparation and quality review of regulatory dossiers, CMC documentation, and client communications.My expertise extends to CBD, CBM, and site transfer projects, where I gained valuable insights into regulatory strategies and compliance requirements. I actively monitor post-approval changes and handle the submission of CBE-0, CBE-30, and PAS applications for the US market.Additionally, I possess solid knowledge of Quality Management Systems (QMS), including change control, errata management, and deviation handling. I\'m also experienced in drug listing via the CDER portal and proficient in preparing and reviewing labeling artwork for pharmaceutical products.
Experience
Regulatory Affairs Officer -ii
Dec 2025 — Present · Bangalore, IN
Education
J.K.K. MUNIRAJAH MEDICAL RESEARCH FOUNDATION, ANNAI J.K.K. SAMPOORANI AMMAL COLLEGE OF PHARMACY (Inst. Code - 082), ETHIRUMEDU
Master of Pharmacy in Pharmaceutical Regulatory Affairs
J.K.K. MUNIRAJAH MEDICAL RESEARCH FOUNDATION, ANNAI J.K.K. SAMPOORANI AMMAL COLLEGE OF PHARMACY (Inst. Code - 082), ETHIRUMEDU
Bachelor of Pharmacy - BPharm
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