Senior Executive

4 days ago

Tandalja, India SUN PHARMA Full time

. Job Title: Senior Executive /Manager 2 = Formulation Development Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G11B / G11A Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description 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 (b) and (b). 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. 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). 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. 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. 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 Travel Estimate NA Job Requirements Educational Qualification M.Pharm or PhD Experience Tenure: 6 to 8 years if M.{harm or 3.5 years if PhD Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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