Sachin Panpaliya
DRA I INDIA REGISTRATION I PRODUCT LIFE CYCLE MANAGEMENT I CHANGE MANAGEMENT I 16+YRS EXPERIENCE
- Role
- Manager, Regulatoty Affairs at Sandoz
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Sachin Panpaliya
Young master candidate in pharmacy having more than 16 years of experience in Drug…
Experience
Manager, Regulatoty Affairs
Apr 2025 — Present · Thane, IN
Liasioning with DCGI and State FDA for getting approvals• Responsible for support in meeting with local business objectives and to support the registration of new products, line extensions, major variations and lifecycle management. • Responsible for liaison with regulators/testing laboratories concerning all regulatory affairs related activities facilitating approvals as CDL, CDTL, IPC etc.• Understand local regulations to support the development and implementation of regulatory and business strategies and decision-making• Application to CDSCO for: Form 45 (Import permission), Form 41 (import registration), Form 10 (Import License), Form 11 (Import license for test and analysis)• Application to State FDA for: Form 24A, 28A (Loan License application), renewal of loan license, WHO GMP application, Form 29 (License for test and analysis for new drug), Export NOC for new drug product, COPP application, FSC application, No conviction certificate for tender, Capacity certificate for tender etc.• FSSAI application for neutraceutical products • To approve the artworks as per country specific labelling requirements for commercial supplies.• Make the other department aware about the new circular/ notices publish by the Authorities and impact assessment/ response to these circularResponsibilities for other scopes:• Life cycle maintenance for In-House products for EU & MoW including renewal, Post approval changes, DL responses • Extension of dossier to major scope i.e. new submission in MoW countries based on EU dossier files.• Life cycle maintenance for Anti TB products for WHO-PQ and other MoW scopes • Preparation of agreed regulatory submission strategy in alignment with all stake holder• Arranging the Legalization of documents in coordination with our public affairs team.• Regulatory evaluation and pre-evaluation for the changes proposed by the stakeholder • Tender registration support
Education
Nagpur University
B.Pharm
2003 — 2007
IPER Wardha
M.Pharm
2008 — 2010
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