Regulatory Affairs Executive Finished Formulation | Regulatory API Executive (US-EUCEP-DMF)|

QA-Technology Transfer Executive | Production-Tech. Transfer Executive | Total 14.6+ Years

Dubai, UAE  |  +971 54 308 4834  |  gnyanrajput@gmail.com  |

Nationality: Indian  |  UAE Employment Visa (valid to 11/2026)  |  Open to relocation across GCC / Africa / EU / Global

PROFESSIONAL SUMMARY
Results-driven Global Regulatory Affairs professional with 14.6+ years spanning Regulatory Affairs, QA-Technology Transfer, and Production-Technology Transfer. Proven track record managing end-to-end dossier lifecycle – registrations, renewals, variations, post-approval changes – across UAE, KSA, Jordan, US FDA (ANDA, US-DMF), Europe (CTD Art.10(1)/10(a), CEP, ASMF), UK MHRA, GCC (UAE MOHAP, SFDA), and 50+ markets across Africa, 6+ CIS, 9+ LATAM, and 9+ ASEAN markets. Skilled in eCTD Module 1-5 (Pharma-Ready, Educe), CMC documentation, and cross-functional coordination with QA, QC, Production, and R&D. Experienced in building regulatory departments, training teams, and securing first-time approvals through proactive gap assessment. Registered QPPV/PV officer with UAE MOHAP.