Vinod R

Experience

1. Asso Dir, Regulatory Affairs

   IQVIA

   Apr 2019 — Present · Bengaluru, IN

   Collaborating with the stakeholders to execute a detailed strategy and implement solutions for overall system governance, data standards, and automation.• Hands on experience with Regulatory Information management for product registration, submission lifecycle and archival.• Contributing to digital projects alongside assigned SMEs and Technology Transformation partners, aligning with Regulatory Affairs priorities and the digital program strategy.• Participating in cross-functional task forces of multidisciplinary experts to execute digital projects and implement data governance.• Identifying necessary documentation and addressing content, quality, and timeline issues for global submissions, negotiating the delivery of approved technical source documents within project timelines.• Authoring and/or reviewing high-quality CMC documentation for Health Authority (HA) submission, adhering to agreed-upon CMC global regulatory strategies, current trends, and guidelines. Ensuring technical congruency and regulatory compliance while meeting e-publishing requirements. • Executing Biologics/Biosimilar submissions such as MAA, CTA/CTA amendments and post approval activities for regulated and rest of the world markets.• Responsible for submission of new applications and Co-ordination with European Health Authorities for various registration procedures (DCP/MRP/NP)/Variations/Renewals and responding to the queries raised by EU authorities within limited time frame.• Compile and submit CMC documentation for both regulated markets and non-regulated markets worldwide.• Conduct regulatory gap analyses and manage various projects aimed at enhancing and updating the CMC dossier.• Plan and monitor the progress of ongoing CMC regulatory projects, ensuring timely notifications to manufacturing sites regarding health authority approvals.