Pankajraj Chigure
Regulatory Operations assistant ll at Fortrea
- Role
- Jr Regulatory Affairs Specialist at Fortrea
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
Experience
Jr Regulatory Affairs Specialist
May 2022 — Present · Pune, IN
Created and updated RMQ as per the regional requirements. Ensured compliance with regulatory requirements in EU, APAC, NA and LATAM.a) EU Cosmetic regulations: 26 Fragrance allergens, EU Reach, OR downstream user, animal testing, CMR, BSE/TSE, GHS, MSDS.b) APAC regulatory requirements: Halal, Kosher, AICS, ADM free, China reach, CSAR and NMPA.c) NA & LATAM regulatory requirements: Canada hotlist, California prop 65, Residual solvents statement as per USP/NF, US food allergen statement.· Handled complex regulatory activities and collaborated with various teams Quality, Toxicology and regional regulatory agencies.· Prepared and reviewed regulatory documents, including quality documents for global markets.· Worked with multiple systems including Concerto, PDS, Specright, Veeva vault and ETQ symphony for change control.· Create and manage global change controls for these revisions to the raw material and packaging specifications· Coordinate and interact with various internal departments like Procurement, Analytical, Technical Assurance, and External manufacturers/sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change· Implement use of consistent, efficient and quality process to meet timelines and deliverables according to regulatory requirements· Ensure compliance of operations with governing regulatory requirements· Create, maintain and assume accountability for a culture of high customer service
Education
Hi-tech College of pharmacy chandrapur
Bachelor of Pharmacy - BPharm
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