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
- Graduating batch 2026, 2027 or 2028 — final-year students and recent graduates welcome
- 60% / 6.0 CGPA and above preferred; strong project work is considered alongside academics
- Working knowledge of USFDA / EMA / CDSCO Guidelines, eCTD Dossier Preparation, Post-Market Surveillance (or a genuine willingness to learn them)
- Exposure to Regulatory Submission Tracking, Labelling & Artwork Review, Change Control Documentation is an advantage
- Clear written and verbal communication in English, and care with detail in your work
- No prior work experience required — this is a fresher-friendly internship
- Based in Pune, Maharashtra or willing to work from there for the internship period
Perks & benefits
Interview & selection process
2 rounds — typical selection flow for this role:
- 1Application screening & resume shortlisting by the talent team
- 2Online aptitude / domain assessment
About Kinaxis India
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