Shashwat Changale
Regulatory Operations Assistant I @ Fortrea | Ex- BSV | GPAT,NIPER Qualified 2021| Regulatory Affairs| Quality Assurance|
- Role
- Regulatory Operations Assistant i at Fortrea
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Shashwat Changale
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Experience
Regulatory Operations Assistant i
Jan 2025 — Present · Pune, IN
Experienced in creating and revising raw material,finished good material,decorated component,packaging component specifications using TRU systems across regions (EMEA, APAC, North America, LATAM). Skilled in managing specifications such as FG (Finish Good), PR (Product Release), DC (Decorated Component), and PC (Packaging Component), including creation, remediation, routing, data mining, and obsolescence.• Proficient in managing global change controls (GCC) for specification revisions and collaborating with internal departments (Procurement, Analytical, Technical Assurance) and external stakeholders (manufacturers, suppliers, distributors) to assess change impact and implement strategies.• Contributed to global sustainability projects by updating and reviewing packaging material specifications (bottles, shippers, cartons, tubes) to align with sustainability goals. Ensures regulatory compliance and upholds high customer service standards.
Education
MET INSTITUTE OF PHARMACY
Master of pharmacy
2021
SVKM's Institute of Pharmacy, Dhule
Bachelor of Pharmacy - BPharm
2017 — 2022
Savitribai Phule Pune University
M Pharm ( Pharmaceutics)
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