Regulatory Affairs Intern

About this internship

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Skills you'll use

What you'll do

• Work on assembling dossiers and tracking submissions across regulators alongside the core team
• Apply USFDA / EMA / CDSCO Guidelines, eCTD Dossier Preparation, Post-Market Surveillance, Regulatory Submission Tracking to live, production-facing problems
• Document your work clearly for reviewers and stakeholders
• Participate in reviews and act on the feedback you receive
• Collaborate across engineering, product, design or business as required
• Follow the team's quality, testing and documentation standards

Who can apply

• Pursuing or recently completed B.Pharm/M.Pharm, B.Sc/M.Sc (Life Sciences / Chemistry) or PG Diploma in Regulatory Affairs — 2026 freshers & final-year students welcome
• Working knowledge of USFDA / EMA / CDSCO Guidelines, eCTD Dossier Preparation, Post-Market Surveillance (or a genuine willingness to learn them)
• Strong fundamentals in your discipline and clear problem-solving ability
• Care with detail and the discipline to document your work
• Clear written and verbal communication in English
• Based in or willing to work from Solapur, Maharashtra

Perks & benefits

Interview & selection process

2 rounds — typical selection flow for this role:

1. 1Application screening & resume shortlisting by the talent team
2. 2Practical assignment or case study with a short walkthrough

About Alkem Laboratories

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