Headline

Regulatory Affairs Associate | RIMS Data Enrichment & EU Lifecycle Management | eCTD | SmPC | CMC | IDMP | EMA SPOR

About

Regulatory Affairs Associate with 1.5+ years of experience in EU regulatory lifecycle management, RIMS data management, SmPC data governance, CTD Module 3 documentation and RIMS workflows. Skilled in eCTD dossier structure, EU variation management (Type IA, IB, II) and IDMP/SPOR standards. Committed to data integrity and regulatory compliance in alignment with ICH guidelines and EMA requirements.

Location

Greater Bengaluru Area

Work experience

Associate 1- Regulatory Affairs at Celegence, Jan 2026 - Present · 6 mos, Bengaluru, Karnataka, India

Junior Associate - Regulatory Affairs at Celegence, Nov 2024 - Dec 2025 · 1 yr 2 mos, Bengaluru, Karnataka, India

Education

Bachelor of Pharmacy, Sri Indu Institutions