Hire Talented CMC Regulatory Associates (Module 3)

Global Regulatory Operations – Regulatory Data & Systems Manager

Aarav Shetty is a seasoned Regulatory Operations and CMC Lifecycle Management professional with 12+ years of global experience across Regulatory Affairs Operations, RIMS, submission publishing, and post-approval product lifecycle management. He specializes in global submissions (US, EU, UK, Middle East, ROW), regulatory data governance, and implementation of RIMS tools such as Veeva Vault, Documentum, Lorenz, and eCTD Express. Aarav has consistently led cross-functional teams, optimized regulatory workflows, and driven automation initiatives to improve compliance, efficiency, and operational excellence in large global pharma environments.

Regulatory Affairs CMC professional

Regulatory Affairs CMC professional with 11+ years of experience in global dossier preparation, lifecycle management, and regulatory submissions for injectable and complex dosage forms. Proven expertise supporting ANDA/MAA filings, post-approval changes, and regulatory strategy across US, EU, and international markets. Experienced in leading cross-functional teams, managing regulatory documentation, and ensuring compliance with FDA, EMA, and ICH guidelines. Skilled in change control evaluation, CMC risk assessment, and coordinating with R&D, quality, and manufacturing to achieve timely and accurate submissions.

Associate Manager – Global Regulatory CMC

Associate Manager – Global Regulatory CMC with 11+ years of experience in regulatory strategy, CMC authorship, and lifecycle management for global markets (US, EU, and ROW). Skilled in preparing and reviewing CMC documentation (Modules 2 & 3), ANDA/NDA submissions, variations, and deficiency responses. Adept at leading cross-functional collaboration across R&D, Quality, and Manufacturing to ensure timely submissions and regulatory compliance. Strong expertise in change control evaluation, global regulatory intelligence, and strategic planning using RIMS tools (Veeva Vault, TrackWise, EtQ Symphony, Doris, CEDMS). Recognized for driving regulatory efficiencies, delivering first-cycle approvals, and managing product ownership throughout the lifecycle.

CMC RC / Regulatory Compliance Specialist

Regulatory Affairs and CMC Regulatory Compliance Specialist with 8+ years of experience supporting global submissions for generic and branded pharmaceutical products. Skilled in preparing and reviewing CMC documentation, lifecycle management, and regulatory submission packages (variations, renewals, annual reports, and market applications). Proven ability to collaborate with cross-functional teams, manage regulatory databases, track post-approval commitments, and ensure timely approvals across US, EU, LATAM, MEA, and ROW markets. Strong experience in regulatory documentation tools (MS Office, XML/x40 authoring tools) with a successful track record in on-time dossier submissions and Health Authority query resolution. Known for process improvement, accuracy, and global compliance execution.

Regulatory Affairs Manager

Regulatory Affairs specialist with 12+ years of experience in CMC authoring, lifecycle management, and global regulatory submissions for biologics, biosimilars, and small-molecule products. Proven expertise in developing regulatory filing strategies, compiling CMC modules (1–3), evaluating change controls, and managing post-approval submissions across regulated markets including US, EU, and MEAR. Strong cross-functional collaborator with experience leading submission planning, Health Authority correspondence, and compliance tracking. Skilled in regulatory systems and eCTD publishing platforms with a consistent track record of delivering timely, high-quality regulatory dossiers and driving process improvements.