Hima Bindu Peravala

Regulatory Affairs professional with 2.5+ years of experience in pharmaceutical Regulatory Operations, supporting EU/UK regulatory submissions, lifecycle maintenance, and CTD/eCTD dossier compilation. Skilled in preparing and reviewing regulatory documentation, managing submission trackers, and performing eCTD publishing using DocuBridge. Experienced in coordinating with cross-functional teams across R&D, Clinical, Medical Writing, and Quality to support timely and compliant clinical trial and marketing authorization activities.

Seeking a Regulatory Affairs Officer role at IQVIA to contribute to high-quality regulatory documentation and publishing for global life science clients.

QA & Regulatory Affairs Associate - Strandhavan Limited T/A Somex Pharma - London, UK

(2023-05 - 2025-07)

• Supported regulatory submissions and lifecycle maintenance for EU/UK products, including MAAs, variations, renewals, and amendments, under the guidance of senior Regulatory Affairs staff.
• Prepared and compiled CTD Module 1–3 documentation for regulatory submissions and lifecycle activities, ensuring accuracy, consistency, and alignment with regulatory guidelines and internal SOPs.
• Performed eCTD publishing and electronic submissions using DocuBridge, managing electronic submission documentation, file structure, and technical validation in compliance with regulatory requirements.
• Managed regulatory databases and trackers to maintain accurate records of products, submissions, and health authority interactions, supporting project timelines and reporting.
• Coordinated with R&D, Clinical Operations, Medical Writing, and Quality Assurance teams to collect and validate documentation (CMC data, analytical reports, labeling, and other supporting documents) for regulatory submissions.
• Conducted gap analysis and dossier review prior to submissions to identify missing or inconsistent information and ensure dossier readiness for health authority review.
• Assisted in managing document-related tasks such as file transfer, version tracking, storage, and archival of regulatory submission documentation to support audit and inspection readiness.
• Collaborated on QMS activities, including change control, deviations, non-conformances, CAPA, and quality risk management, strengthening overall regulatory compliance and continuous improvement.

Assistant Professor - T.V.M College of Pharmacy, Bellary, India - Bellary, India

(2021-11 - 2022-09)

• Taught undergraduate pharmacy courses in Pharmacotherapeutics and Pharmacology, and developed lesson plans and assessments.
• Contributed to curriculum development and supported students with academic advising.

Master's - Clinical Pharmacology - University of Glasgow, Scotland, United Kingdom

Doctor of Pharmacy - Pharmacy - Rajiv Gandhi University of Health Sciences, India