Udaya Kumar Nayak
18 yr of R&D -Plant Exp. across pharma industry. Currently in leadership position. Proficient in development, commercialization of ANDA-Topical, solid, soft gel, liquid. Ex-Glenmark, Ex-stride, Ex- Encube & Ex-Ajanta
- Role
- General Manger & Head- Formulation & Development at Marksans Pharma Ltd. - India
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Udaya Kumar Nayak
Well expertise in cross functional leadership, product development, process design…
Experience
General Manger & Head- Formulation & Development
May 2022 — Present · Mumbai, IN
Coordinating with stakeholders and CFTs to ensure the allocated projects are carried out and completed successfully Providing Senior Management with high level weekly and monthly summary reports Key role play in Topical Department set up and manage development mile stone in time Spearheading overall formulation development activities during the product development life cycle processes Play key role in Strategy finalization of product development for US market, cosmetic product, OTC – US and Hormonal product. Responsible for department budget preparation with proper justification Facilitating Analytical Dept, Regulatory Affairs, Purchase- EXIM, and Tech. Transfer - Plant, commercial team for the product life cycle activity. Ensuring FDA deficiencies response / Letters in line with regulatory and scientific technical justification Contributing a key role during new updated technology absorption at in house site. Review and approve documents, like department SOP, method development protocol and report, BOM, MFC, BMR, PDR, regulatory justification, stability data report, product specification, test method, technology transfer report, master documents, equipment qualification and calibration related documents Controlling the R&D needs pertaining to innovation and productivity Managing process validation activity for ANDA products and guided approach for smooth commercial batch execution with same and higher batch size at large manufacturing scale. Handelling development for regulated markets like US, Europe and Canada. Filings were Para IV filing, ANDA para product, IVRT based product and complex generics. Also hands on experience on first time India market pharma, nutraceutical and cosmetic-OTC product Directing and leading CRO based outsource product development both domestic and international location. Determining areas of improvement, implementing corrective actions for improvement of quality, and managing troubleshooting activities
Education
University Of North Bengal
M. pharm (pharmaceutics), Pharmacy
COLLEGE OF PHARMECEUTICAL SCIENCES, MOHUDA
B. Pharmacy
2000 — 2004
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Abbreviated New Drug Application (Anda)
- Pharmaceutics
- Regulatory Affairs
- Innovative
- Gmp
- Event Planning
- Drug Delivery
- Validation
- Formulation
- Glp
- Anda
- Strategy Development
- Technology Transfer
- Generic Programming
- Event Execution
- Strategy
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