Neha Mohandas
Senior Manager | Global Regulatory Affairs CMC | MSAT & DSP Expertise
- Role
- Senior Manager at Biocon Biologics
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Neha Mohandas
Accomplished biopharmaceutical professional with 12+ years of expertise in global regulatory affairs, downstream processing, and manufacturing support. Proven success in leading regulatory strategies for biosimilar biologics across advanced markets including the US, EU, UK, Canada, and Switzerland. Recognized for bridging scientific rigor with regulatory insight to accelerate product development, approvals, and market access.
Experience
Senior Manager
Nov 2025 — Present · Bengaluru, IN
Directed global regulatory activities for biosimilar biologic products securing market authorizations across US, EU, UK, Canada, and Switzerland. Led BLA, MAA, and NDS submissions ensuring strategic alignment with health authority expectations and partner timelines. Authored and reviewed comprehensive regulatory packages including Module 1 (administrative), Module 2 (summaries), and Module 3 (CMC). Developed and executed response strategies to regulatory queries, enabling accelerated approvals. Managed post-approval lifecycle activities, ensuring compliance and commercial continuity. Engaged with global health authorities to secure scientific advice and regulatory alignment.
Education
Vidyavardhini
HSC, Science
2007
K.I.T.'s College of Engg.
Bachelor of Engineering (B.E.), Biotechnology
2007 — 2011
Institute Of Chemical Technology
Master of Technology - MTech, Bioprocess Technology
2011 — 2013
Vidya Vikasini
SSC
2005
Skills
- Mass Spectrometry
- Research
- Spectrophotometry
- Hplc
- Microsoft Word
- Microsoft Excel
- Powerpoint
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