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Executive – Regulatory Affairs

LupinPune, IndiaPosted 18 May 2026

Lupin is seeking a Regulatory Affairs Executive to manage licensing applications and regulatory documentation within the biotech sector. The role involves preparing dossiers in CTD/ACTD format, handling post-approval variations, and responding to regulatory queries. Candidates will also review CMC documents and manage submissions via online portals. This is an onsite role based in the Pune/Pimpri-Chinchwad area requiring specific biotechnology or biochemistry educational background.

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Experience

2-3 years

Function

Research

Work mode

Onsite, India

Company

Tier 2

What you will work on

Lupin is seeking a Regulatory Affairs Executive to manage licensing applications and regulatory documentation within the biotech sector. The role involves preparing dossiers in CTD/ACTD format, handling post-approval variations, and responding to regulatory queries. Candidates will also review CMC documents and manage submissions via online portals. This is an onsite role based in the Pune/Pimpri-Chinchwad area requiring specific biotechnology or biochemistry educational background.

TAL's take

Quality 60/1005/5 clarityTier 2 company

Stable established pharmaceutical firm with a well-defined role in regulatory affairs.

The JD is highly specific to regulatory documentation and licensing processes within the biotech sector.

Salaries at Lupin

15.2 LPA average

Based on 3 Grapevine salary entries for Lupin.

View all salaries

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Other roles

8 - 10 years

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Range: 29 - 29 LPA

Must haves

  • 2-3 years experience in Biotech regulatory department
  • Experience with CLAA and SLA licensing
  • Knowledge of CTD/ACTD dossier preparation
  • Review of CMC documentation
  • Experience with online regulatory portals

About the company

Lupin is an established pharmaceutical company with global operations.

Posts mentioning Lupin

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