プロフィール詳細

プロジェクトを作成

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Vinay D.に依頼

India

Regulatory Affairs Specialist | Global CPP Procurement & Legalization | 10+ Regulated Markets | Organon India

プロフィール概要

Pharmaceutical companies lose registrations not because their products fail — but because their documentation does. I make sure that never happens. I am a Regulatory Affairs professional with 2+ years of progressive experience at a global MNC (Organon India), specializing in end-to-end Certificate of Pharmaceutical Product (CPP) procurement, apostille and consular legalization, and ancillary documentation management across 10+ regulated international markets. My track record is measurable: I have processed 60–80 CPPs monthly with zero Health Authority rejections or observations, reduced CPP procurement cycle times by 30% through redesigned Excel tracking systems, and improved export dossier document accuracy by 25% through standardized review processes. I have direct working experience with the world’s most demanding Health Authorities — FAMHP (Belgium), CIBG/MEB (Netherlands), EMA (EU), USFDA (USA), Swissmedic (Switzerland), HSA (Singapore), BPOM (Indonesia), Health Canada, and MHRA (UK). I understand each authority’s documentation requirements, legalization pathways, and common rejection points. Beyond CPP, I manage GMP Certificates, Drug Licenses, AFEX procurement documentation, and regulatory intelligence monitoring — synthesizing 50+ regulatory updates per quarter into actionable compliance briefings for global regulatory and supply chain teams. I hold an M.Pharm in Pharmaceutics (CGPA 8.23) and have published two peer-reviewed research papers in Springer Nature journals. I work best with: Pharma exporters, CMOs, regulatory consultancies, and global MNCs who need a reliable, detail-oriented CPP and export documentation specialist — not a generalist.

専門分野

• ★ Regulatory Affairs
• ☆ Publishing
• ☆ Excel
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Regulatory Writing
• ☆ CMC Documentation

サービス

• Research
• Consulting
• Product Development

Research Gap Analysis

Consulting Regulatory Consulting

Product Development Product Compliance

職務経験

Associate Specialist Regulatory Affairs

Organon Laboratories Ltd

10月 2024 - 現在

学歴

Master of Pharmacy M.Pharm Pharmaceutics

Government College of Pharmacy, Maharashtra

1月 2021 - 1月 2023

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

Vinay Deshmukh, Yogesh V. Pore, Rais Shikalgar, G. S. Bangale, Sonu Rathod, D. P. Pawar (2024). Optimizing Nimesulide Loaded Cubosomal Gel for Enhanced Efficacy: A Systematic Engineering Approach with Factorial Design for Topical Applications . Journal of Pharmaceutical Innovation.