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⏰ Full-time

CMC Regulatory Affairs Lead

Biocon
Location 📍 Bengaluru, India
Posted 📅 June 02, 2026
Work Type ⏰ Full-time

Position Overview

Key Responsibilities


1. Regulatory Filing & Approval Management

- Own global tracking of regulatory filings, approvals, commitments, and health authority queries across molecules and markets.

- Maintain molecule-wise and market-wise dashboards covering planned vs actual submissions and approvals.

- Ensure accuracy, clarity, and timely updates of regulatory status to stakeholders.


2. Cross-Functional Team (CFT) Orchestration

- Act as the primary coordination point between Regulatory Affairs, CMC, Clinical, Quality, Supply Chain, and Commercial teams.

- Identify critical path activities and interdependencies impacting submission and approval timelines.

- Drive action closure across teams and escalate risks with data-backed mitigation options.


3. Filing Readiness & Execution Governance

- Lead filing readiness checkpoints ...

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Job Details

Employment Type
Full-time
📊
Category
Business Operations Specialists
🏠
Work Arrangement
On-site
📍
Location
Bengaluru, India