Umesh Ingole

About Umesh Ingole

Regulatory Affairs professional highly passionate about my profession and committed in…

Experience

1. Senior Manager- Regulatory Affairs (Us)- Injectables and Osd (Complex and Combination Products)

   Endo Pharmaceuticals

   Oct 2018 — Present · Mumbai, IN

   Review and Submission of NDA (505(b)(2))/ANDA for Sterile dosage forms (Sterile Solution injectables, lyophilized powder, Complex Injectable Products- Peptides, Long Acting Injectables, Liposomes Injectables etc. & Combination Products- Pre Filled Syringes (PFS), IV infusion bags and Ophthalmic products.• Handling First to File (FTF) and Paragraph-IV ANDA submission.• Handling Complex Injectable Products- Peptides, Long Acting Injectables, Liposomes Injectables etc. & Combination Products- Pre Filled Syringes (PFS), IV infusion bags.• Review and submission of controlled correspondences to FDA.(e.g.Q1/Q2, MDD, IIG etc.)• Review and submission of Pre-ANDA development/submission meeting for Complex Products with FDA.• Review and submission of Pre-IND (Type B) and Type C meetings for NDA (505(b)(2)) applications with FDA.• Preparation of Regulatory Strategy/ CMC requirements for new pipeline injectable (Complex and Combination) products. • Review and Submission of supplement packages Annual report, PAS, CBE and CBE-30.• Review and Compilation of quality response for Information Request/ECD/ Complete Response letter (CRL) to Agency.• Thoroughly Review of CMC (chemistry, manufacturing and controls) sections for NDA/ANDA.• Handling eCTD publication through Extedo Software.• Collation and review CMC of documents (i.e. PDR, BMR, BFR, Specifications, Validation reports etc.) from F&D, AMD, QA, production, packaging department and review of data for dossier preparation

Skills

• Anda
• Ich Guidelines
• Abbreviated New Drug Application (Anda)
• Drug Delivery
• Regulatory Affairs
• Fda
• Technology Transfer
• Gmp
• R&D
• Ectd
• Pharmaceutics