Santanu Chakraborty
Head of Osd R & d - India @Viatris
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WORK HISTORY
Head of Osd R & d - India @Viatris
Hyderabad, IN
Leading a team of about 250 scientists, involve in product development, dossier submission, securing approval on time of immediate & modified release oral solid dosage forms (like Tablets, Capsules, PFOS, MUPS) from various regulatory agencies like US-FDA, EMA, TGA, HC, SAHPRA, MEDSAFE, PMDA, CDE, ROW, WHO & PEPFAR and their commercialization. Responsible for topical product development for regulated markets, and collaborative product development with partner companies.Assess potential risk if any, and derive proper mitigation plan. Work closely with Regulatory and Clinical group to derive appropriate clinical and submission strategy. Responsible for attending the PAI of USFDA w.r.t drug product development.Identifying the risk and derive adequate mitigation plan to ensure timely launch.Responsible for proposing the department budget and review it periodically to ensure adherence with the proposed budget. Responsible as a 30(b)(6) witness in deposition/litigation.Identify, groom, reward and develop high performers and future leaders within the team.Achievements:50+ PIV Submissions, including FTF & NCE-1.Some good numbers of successful 505(b)(2) submissions.Successful deposition in several litigations as corporate 30(b)(6) witness.Was instrumental in contributing to both organic and inorganic growth of the company.Developed and commercialized some highly complex and unconventional technology driven products, involving Hot Melt Extrusion, Nanonisation, Spray drying, Dry powder coating etc.One of the inventors of several patents.
EDUCATION
Jadavpur University, Kolkata
Bachelor of Pharmacy - B. Pharm
Jadavpur University, Kolkata
Master of Pharmacy - M. Pharm (Pharmaceutics)
Andhra University, Visakhapatnam
Doctor of Philosophy - PhD
SKILLS
ABOUT SANTANU CHAKRABORTY
A seasoned Pharmaceutical Product Development professional with more than 28 years of rich experience in product development of oral solid and topical dosage forms, BA/BE & Clinical Studies, IPR & Drug Regulatory Affairs. Well versed with ideation to commercialization of finished pharmaceutical products and its life cycle management for different regulated markets. Experienced in successful addressing of post submission regulatory queries, post approval commercialization and product life cycle management. Expertise in developing complex and difficult to develop generics through 505(j) and 505(b)(2) routes. Sound understanding as 30(b)(6) corporate witness in US litigations. Knowledge blended with experience and expertise along with management skills and leadership qualities. Presently, engaged in a highly challenging leadership role in one of the topmost generic companies of the world. One of the inventors of several patents.Hold an honorary position in department academic advisory committee of the department of Pharmaceutics at NIPER-Guwahati, Assam.
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