Prajwal Dake
junior Regulatory affairs specialist
- Role
- Process Associate (Regulatory Affairs) at Tata Consultancy Services
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Prajwal Dake
Evaluation of specification, Residual solvent statement and Certificate of analysis for RS assessment. • work on EU region to update specifications for the Type I & Type II variations. • Having knowledge of Q3C guideline and PDE calculation. • Support on project Stability for report authoring and verification. • Create, revise and/or obsolete specifications for global packaging development using TRU. • Create and manage global change control (GCC) for specifications. • Evaluation of artwork for dose and MDD evaluation. • Worked on citrix (ELN) and global formula app under Global residual solvent assessment project. • Having knowledge of IPEC Nitrosamine impurities risk evaluation. • Work on packaging related tasks such as bill of materials, artwork review, purchase orders, raw material codes. • Coordinate with various internal departments, suppliers and distributors to collate required information/documentation governing the changes, as applicable. • Managing day to day operations and delivery for the projects. • Implement use of consistent, efficient, and quality process to meet timelines and deliverables. • Assist in preparation of work instructions/ standard operating procedures.
Experience
Process Associate (Regulatory Affairs)
Jun 2025 — Present
Education
Shivaji University
Bachelor of Pharmacy - BPharm
2016 — 2020
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.