Navaneethakrishnan P
Pharmaceutical Regulatory Science CMC Associate (USA, EU, RoW) at Harman Finochem 💊| Ex-Pfizer🧬 | Ex-Endo Pharma💊 | TNMGRMU 🎓| Master of Pharmacy (Pharmaceutics) - Medal 🏅| Pharmacist🥼
- Role
- Research Associate - Regulatory Affairs Cmc at Harman Finochem Ltd
- Location
- Tiruppur, IN
- LinkedIn followers
- 500 followers
About Navaneethakrishnan P
Dear Linkedin Member, I am a Regulatory Affairs Professional with 5 years of…
Experience
Research Associate - Regulatory Affairs Cmc
Feb 2024 — Present · IN
Prepare, review, compile, and submit dossiers for ANDA, post-approval and annual reportable changes to regulatory agencies (US-FDA, EMA, Health Canada, and ROW countries).• Maintain records of drug product history, including filing history with agencies/customers and any amendments made.• Monitor updates and changing requirements from regulatory agencies, providing guidance to align in-house activities accordingly.• Handle the application, documentation, and renewal of regulatory licenses, including Import Licenses (Form 12 and Form CT16) and Manufacturing Licenses for Test and Examination (Form CT10 and Form 29), ensuring compliance with all relevant CDSCO regulations.• Oversee the review and approval of regulatory CMC documents generated at R&D and commercial manufacturing facilities, ensuring strict adherence to regulatory standards.• Provide expert guidance to R&D scientists on formulation development processes, advising on relevant guidelines, laws, and regulations.
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