Regulatory Affairs Intern
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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 Kolhapur, Maharashtra
Perks & benefits
Interview & selection process
2 rounds — typical selection flow for this role:
- 1Application screening & resume shortlisting by the talent team
- 2Practical assignment or case study with a short walkthrough
About Navin Fluorine International
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