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Ketan Pareekh
Regulatory Affairs CMC professional
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.
FORMERLY AT
Gland Pharma Ltd.
LOCATION
Hyderabad
AVAILABILITY
Full-time
Skills
Adobe Acrobat
Adobe Acrobat DC Pro
Documentum
Documentum (D2)
Lorenz Docubridge
MS Office
TrackWise QMS
Work Experience
Regulatory Affairs CMC professional
Gland Pharma Ltd.
October 2024 – Present
- Responsible for compiling, reviewing, and submitting CMC dossiers for injectable formulations in compliance with global regulatory standards.
- Manage change controls and provide regulatory response strategies to Health Authorities.
- Lead and mentor a team, ensuring timely and accurate submissions and project updates.
TECHNOLOGIES
Lorenz DocuBridge, Documentum (D2), TrackWise QMS, MS Office, Adobe Acrobat DC Pro
Deputy Manager – Global Regulatory Affairs
Mylan Laboratories Ltd. (Viatris)
September 2018 – October 2024
- Managed global CMC dossier submissions for injectable and complex generic products including emulsions, liposomes, peptides, and nanosuspensions.
- Oversaw CMC strategies for drug–device combination products (PFS, kits, infusion bags). Acted as liaison between technical writing teams and global leadership, ensuring regulatory compliance and timely dossier submissions.
TECHNOLOGIES
Documentum, Lorenz DocuBridge, MS Office
Assistant Manager – Global Regulatory Affairs
Dr. Reddy’s Laboratories Ltd.
August 2015 – September 2018
- Supported CMC activities from development through lifecycle management and post-approval changes.
- Authored CTD content updates and ensured alignment with manufacturing process changes.
- Participated in Health Authority interactions and developed training modules for departmental capability building.
TECHNOLOGIES
Documentum, MS Office, Adobe Acrobat
