Alkem Laboratories

Regulatory Affairs Intern

InternshipHybridHassan, Karnataka3 months16K/mo2 openingsImmediate / Rolling

About this internship

Alkem Laboratories is hiring a Regulatory Affairs Intern in Hassan — a hands-on, mentor-led internship built for students and 2026 freshers who want real exposure to pharmaceutical regulatory affairs rather than a certificate-only programme. About the role As a Regulatory Affairs Intern at Alkem…

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Skills you'll use

USFDA / EMA / CDSCO GuidelineseCTD Dossier PreparationPost-Market SurveillanceRegulatory Submission TrackingLabelling & Artwork ReviewChange Control DocumentationQuery Response DraftingRegulatory IntelligenceTechnical WritingQuality Documentation

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 Hassan, Karnataka

Perks & benefits

Exposure to professional tools and workflowsPre-Placement Offer (PPO) opportunityFlexible working hoursNetworking with senior professionalsInternship Certificate

Interview & selection process

4 rounds — typical selection flow for this role:

1Application screening & resume shortlisting by the talent team
2Technical interview on fundamentals and your projects
3Practical assignment or case study with a short walkthrough
4HR discussion — stipend, start date, expectations and offer

About Alkem Laboratories

Alkem Laboratories operates in the pharmaceuticals sector and has an active presence in Hassan. Interns here are put on real work from the start, because the team's view is that the fastest way to learn a craft is to practise it under people who already do it well — not to watch it from a…

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