Tanvi Kathuria

Detail-oriented Project Management Officer with expertise in regulatory compliance and global regulatory affairs. Experienced in project tracking and team collaboration to support client deliverables. Proficient in document management and coordination. Thrives in fast-paced environments, ensuring timely submissions and adherence to ICH guidelines.

Project Management Officer at Genedrift Global Services Pvt. Ltd. (2025-06 – Present)

• Coordinated regulatory projects for pharmaceutical product registrations across Myanmar, Philippines, Vietnam, Singapore, GCC, and other global regions.
• Collaborated with cross-functional teams and international clients to support regulatory submissions and lifecycle management activities.
• Managed project timelines and collaborated with Regulatory Affairs, Commercial, and Technical teams to ensure timely submissions.
• Coordinated collection of regulatory documents, including LCVs, COPP, COA, Stability Data, Manufacturing Licenses, and Product Permissions, facilitating timely accurate submissions.
• Reviewed regulatory dossiers for completeness and readiness for client submission, improving compliance and increasing client satisfaction.
• Conducted quality checks on dossiers and manufacturing site documentation during labeling review, ensuring adherence to regulatory standards for timely submissions.
• Coordinated the review and compilation of CTD/eCTD CMC dossiers (Modules 2 & 3) for global regulatory submissions, ensuring dossier completeness.
• Coordinated the preparation and submission of responses to Health Authority queries and deficiency letters.
• Tracked regulatory deliverables and coordinated the resubmission of responses by coordinating with clients and internal teams.
• Communicated with international clients to resolve documentation queries and track regulatory deliverables.
• Prepared Meeting Minutes (MoMs), maintained project trackers, and monitored action items.

Industrial Trainee at Industrial Trainee Unix Biotech Pvt. Ltd. (2024-07 – 2024-08)

• Supported quality assurance, quality control, production, and packaging processes to maintain product standards.
• Applied GMP pharmaceutical documentation, and quality compliance practices in daily tasks.
• Performed routine quality checks on raw materials and finished products to ensure consistency and meet quality specifications.
• Assisted in laboratory procedures and maintained equipment for biotechnological experiments.
• Worked with team members to uphold compliance with safety standards and protocols, enhancing workplace safety.

M.Pharm in Pharmaceutical Regulatory Affairs – Chitkara University (2026-07)

Bachelor of Pharmacy in Pharmacy – Maharishi Markandeshwar (Deemed to be University) (2024-07 – 2024-07)