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U. Bhavna
U.Bhavna
Senior Executive – Regulatory Affairs
U. Bhavna is a Regulatory Affairs Senior Executive with over 9 years of experience in managing regulatory submissions, dossier compilation, and CMC documentation for injectable and oral solid dosage formulations. She specializes in ANDA and CTD submissions, analytical and manufacturing document review, stability data assessment, and post-approval lifecycle management. Skilled in regulatory compliance across USFDA, EU, and WHO guidelines, Bhavna effectively coordinates with cross-functional teams to ensure timely submissions and approvals. Her strong technical acumen, audit experience, and proactive problem-solving approach contribute to achieving successful regulatory outcomes in global markets.
FORMERLY AT
Hetero Labs Limited
LOCATION
Hydrabad India
AVAILABILITY
Full Time
Skills
ANDA
CMC
Document Management Systems
LIMS
Quality & Stability Management SystemsCTD
TrackWise
Work Experience
Senior Executive – Regulatory Affairs
Hetero Labs Limited
August 2023 – Present
- Responsible for ANDA filing, review, and submission activities.
- Draft and review CTD dossiers and regulatory documentation to support pre- and post-approval submissions in compliance with international guidelines.
- Conduct CMC submissions ensuring high-quality documentation and adherence to regulatory standards.
- Provide cross-functional regulatory support, identify documentation requirements, and coordinate project deliverables within defined timelines
TECHNOLOGIES
CTD, ANDA, CMC Documentation, TrackWise, PharmaReady, LIMS
Executive – Regulatory Affairs
Natco Pharma Limited
December 2015 – July 2023
- Managed regulatory submissions for ANDAs and ensured accuracy of dossiers and supporting documentation. Reviewed DMFs, manufacturing, analytical, and stability reports for compliance with global standards.
- Oversaw CMC amendments, annual reports, and post-approval changes.
- Conducted risk assessments, supported audits, and efficiently resolved technical queries from regulatory authorities and clients.
TECHNOLOGIES
CTD, ANDA, CMC, TrackWise, LIMS, Document Management Systems
Officer – Quality Assurance
Natco Pharma Limited
Jan 2015 to Oct 2015
- Reviewed analytical and stability reports, validation protocols, and environmental data for accuracy and regulatory compliance. Managed OOS/trend investigations, ensured data integrity, and prepared process validation and verification reports.
- Conducted review of BMRs and BPRs to maintain GMP compliance.
TECHNOLOGIES
TrackWise, LIMS, Quality & Stability Management Systems
