Sun Pharma Require FRD Non-Orals Manager

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Manager 2 - FRD Non Orals

Job Description
1. Experience in end-to-end topical product, parenteral product (injection) product development activities for generic product development ANDA (Cream, ointment, gel, solution, lotion, foam, patch, solution injection, depo injection, prefilled syringe, cartridge based injection etc.) as well as NDA 505(b)(2) and 505(b)(1).
2. Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA.
3. Experienced scientist to perform experiments for development of optimum prototypes (generic, non-infringing composition and robust manufacturing process) with diverse class of drugs & prodrugs (sensitive to pH, acid, base, temperature, oxygen, humidity).
4. Experience in regulatory documentation CMC, MF, BMR, PDR, controlled correspondence for CMC, Biowaiver & Dossier preparation for US-FDA, EU-EMA, AU-TGA & DCGI through successful filing.
5. Experience in working with cross-functional teams (ADD, MSTG, production, QC, QA, RA, IPC, PMO, BD, Microbiology, Pharmacology etc.) to achieve project goals - Filings and subsequent approvals.
6. Knowledge and develop continuous understanding on competitive intelligence, due diligence, US-FDA quality concepts, statistics and global pharma trend analysis to support new product evaluation & introduction

Additional Information
Tenure : 6 to 8 years if M.{harm or 3.5 years if PhD
Qualification : M.Pharm or PhD
Location : Baroda
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Formulation Development Non Orals
End Date : 28th February 2026