N N Pavan Kumar
Regulatory Affairs CMC Lead (Biologics & Biosimilars) | PhD Candidate | Global Submissions (FDA/EMA/ROW) | Six Sigma Green Belt
- Role
- Manager at SUN PHARMA
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About N N Pavan Kumar
Regulatory Affairs CMC expert with over 10 years of experience in the Biologics and Biosimilars industry. Currently managing life cycle global regulatory Submission for the Biologics at Sun Pharma.Core Expertise:Global Submissions: Proven track record in authoring and reviewing IND/BLA/MAA dossiers for US (FDA), EU (EMA), and emerging markets.Strategic Compliance: Skilled in leading Scientific Advice meetings, gap assessments, and mitigating regulatory risks early in development.Technical Foundation: Deep background in Analytical Method Development and Characterization, enabling strong technical defense of CMC data.
Experience
Manager
Oct 2025 — Present · Gurugram, IN
CMC Lifecycle Strategy: Define and own the global CMC regulatory strategy for the biologics, ensuring seamless lifecycle management (LCM) from late-stage development through commercialization and post-approval maintenance.Regulatory Submissions & Strategy: Drive the end-to-end preparation, review, and submission of high-quality CMC dossiers (Module 3) for initial filings (BLA/MAA), market expansions, and complex post-approval variations across US, EU, and emerging markets.Cross-Functional Leadership: Lead cross-functional CMC teams (Process Sciences, QA, QC, Supply Chain) to execute critical regulatory activities, including response strategies for Health Authority queries and post-marketing commitments.Team Development: Mentor colleagues and contribute to building robust CMC regulatory expertise and best practices within the organization.
Education
Indian Statistical Institute(SQC & OR)
Statistical Quality Control (SQC), Statistics, quality control
2019 — 2020
Indira Gandhi National Open University
PGDM IN IPR, Intellectual Property rights
2020 — 2020
Jawaharlal Nehru Technological University
Master of Technology (M.Tech.), Biotechnology
2014 — 2016
D.V.R & Dr.H.S MIC College of Technology,JNTU-Kakinada
Engineer's Degree, B.Tech (Biotechnology)
2010 — 2014
Vignan's Foundation for Science, Technology & Research
Doctor of Philosophy - PhD, Biotechnology
2026
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