Nikhil Patil
Executive Regulatory Affairs (US Market) - Micro Labs Ltd | M.Pharm - PTF (NIPER S.A.S. Nagar) | NIPER JEE AIR 15 | GPAT AIR 11 | Gold Medalist (B. Pharmacy) - RCPIPER, Shirpur, Maharashtra
- Role
- Regulatory Affairs Executive (Us Market) at Micro Labs Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Executive (Us Market)
Jul 2024 — Present · Bengaluru, IN
Driving regulatory submissions of ANDA generics Products for US market specially for Sterile generic products (Ophthalmic & Otic - Solution, Suspension & Emulsion, Injection, Inhalation Solution & Suspension)Regulatory Affairs:1. Preparation, review and filing of ANDA dossiers for US Market.2. Expertise in technical CMC documents review (ARD, QA, FRD, QC, DMF/ASMF, Vendor Docs- API, RM, PM), as well as coordinating cross-functional teams for dossier data requirements.3. Expertise in handling queries (IR, DRL and CRL) with timely submissions to regulatory agencies.4. Filing of Q1/Q2 and other Control Correspondence with regulatory agency during the ANDA review cycle5. Exposure to Europe & UK market dossier.(CEP, ASMF, DSM, DPM)6. Preparation & submission of Change being effected (CBE- 30, 60), Prior-approval supplement (PAS) regulatory agency7. Filing Request for reconsideration (RFR), CGT designation request, Pre-launch activities importation request (PLAIR), Gratuitous amendment with regulatory agency8. Familiar & Proficient in handling- orange book, Drugs@fda, Dailymed, Dissolution database, IIG database, FDA drug shortage (discontinuation), Impurities calculations (F2, Nitrosamine, Genotoxic, RS, RSL, EI), REMS, product specific guidances, CTD modules & submodules, FDA guidances, nitrosamine subclasses9. Familiar & Proficient in handling- EMA (Centralized), MRI index (Decentralized), National Register, EMC (UK), NZ, Australia, Article 57 databse, MHRA Products, CEP, ASMF, Pharmacopeial monographs (US, EU, BP), ICH guidelines, reflection paper, PIL, SmPC. Coordinated effectively projects with external CROs, Managed project timelines, tracked key activities, and facilitated communication through regular meetings and meeting minutes (MOM).
Education
National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali
M. Pharmacy, Pharmaceutical Technology and Formulation
S.S.M.M. College of Arts, Science & Commerce, Pachora
F.Y.J.C(11th) & S.Y.J.C (12th), Science (Biology & Mathematics)
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