Profile Details

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Hire Vinay D.

India

USD 20 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• Research
• Consulting
• Product Development

Research Gap Analysis

Consulting Regulatory Consulting

Product Development Product Compliance

Work Experience

Associate Specialist Regulatory Affairs

Organon Laboratories Ltd

October 2024 - Present

Education

Master of Pharmacy M.Pharm Pharmaceutics

Government College of Pharmacy, Maharashtra

January 2021 - January 2023

Certifications

• Certification details not provided.

Publications

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.