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Tanuj Chaurasia
CMC RC / Regulatory Compliance Specialist
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.
FORMERLY AT
AstraZeneca India Pvt. Ltd.
LOCATION
Chennai
AVAILABILITY
Full-time
Skills
Dossier Compiling & Tracking Tools
GENAR Regulatory Database
internal trackers)
MS Office
MS Office Suite
Regulatory Tracking Systems (GENAR
Submission Tracking Tools
XML/x40 Authoring Tools
Work Experience
CMC RC / Regulatory Compliance Specialist
AstraZeneca India Pvt. Ltd.
Apr 2013 – Dec 2014
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Produced CMC documentation packages to support lifecycle management of commercial products.
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Managed post-approval compliance activities including license renewals, variations, and annual reports (US/Brazil), as well as EU MRP submissions.
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Coordinated cross-functional teams to ensure timely submission and regulatory alignment.
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Supported implementation of compliance improvement plans and registration tracking.
TECHNOLOGIES
MS Office Suite, XML/x40 Authoring Tools, Regulatory Tracking Systems (GENAR, internal trackers)
Assistant Manager – Regulatory Affairs (Branded Generics)
AstraZeneca India Pvt. Ltd.
Jul 2010 – Mar 2013
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Led submission of 50+ registration dossiers for LATAM & MEA regions and secured regulatory approvals.
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Developed and implemented GENAR – Global Regulatory Database for Generic Products.
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Managed Product Information Tracker for PSURs, label updates, and submission progress.
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Liaised with regulatory agencies and internal stakeholders to resolve HA queries.
TECHNOLOGIES
MS Office, GENAR Regulatory Database, Submission Tracking Tools
Full-Stack Developer
American Express
2021
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Prepared registration dossiers for ROW markets and handled Health Authority deficiency responses.
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Coordinated with manufacturing, QC, and QA teams to compile CMC documentation.
TECHNOLOGIES
MS Office, Dossier Compiling & Tracking Tools
