Prathibha H Gowda
SME Drug Regulatory Affairs
Bangalore
Summary
Seasoned Drug Regulatory Affairs professional with 14 and half years of experience in pharmaceutical industry, specialized in project management, regulatory strategy, and life cycle management of drug products for regulated markets. Proven expertise in handling dossier submissions, compliance audits, regulatory data management, and stakeholder management with good analytical skills with a strong focus on efficiency and quality.
Overview
20
20
years of professional experience
30
30
years of post-secondary education
Work History
Lead Consultant (Assistant Manager)
Genpact India Pvt. Ltd.
02.2021 - Current
- Authored work procedures for dossier submission planning in Veeva Vault for global markets.
- Led regulatory data cleansing & enrichment, quality check for RIMS migration projects.
- Skilled in using Advanced Excel techniques (Pivot, VLOOKUP, text functions) for data optimization.
- Ensured compliance through QC reviews aligned with regulatory & client requirements.
Team Leader, Regulatory Affairs
Apotex Research Pvt. Ltd.
10.2015 - 06.2016
- Managed high-priority ANDA Data Integrity (DI) reports for USFDA Inspection clearance.
- Coordinated across Apotex Canada, US & India teams for regulatory compliance for ANDAs.
Sr. Regulatory Affairs Specialist
Sciformix Tech. Pvt. Ltd.
11.2014 - 10.2015
- Led ANDA Data Integrity (DI) project, evaluating USFDA warning letters.
- Facilitated scientific writing for EU regulatory submissions (Module II reports).
- Interviewed 30+ candidates in a recruitment drive.
Senior Executive, Regulatory Affairs
Agila Specialties Pvt. Ltd.
02.2010 - 10.2014
- Managed 20+ ANDA filings for injectable drug products.
- Oversaw post-approval supplements (PAS, CBE-30) & regulatory compliance.
- Solely responsible for 50+ Annual Reports & 15+ PADER filings.
- SPOC for a US joint venture RA business- for Sagent Pharmaceuticals.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
- Defined clear targets and objectives and communicated to other team members.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
Junior Manager, Development QA
Dr. Reddy's Laboratories
07.2007 - 08.2008
- Implemented QbD principles and conducted internal audits.
- Reviewed & approved analytical method development & validation reports, RM, FP, shelf-life specs, Product development reports, pilot, pivot batch data for global regulatory submissions.
Scientist II, R&D QA
Torrent Research Centre
05.2005 - 06.2007
- Conducted internal audits, vendor audits, and risk management.
- Supported QbD implementation & external vendor evaluation.
- Reviewed & approved analytical method development & validation reports, RM, FP, shelf-life specs, Product development reports, pilot, pivot batch data for global regulatory submissions.
Education
B. Pharma -
Shree Siddaganga College of Pharmacy
01.1998 - 01.2002
M. Pharma - undefined
Al- Ameen College of Pharmacy
01.2003 - 01.2005
Certification Program - Regulatory Affairs
International Drug Regulatory Affairs
Online 04.2001 - Current
Discover Veeva RIM Certification - Veeva Vault
Veeva Systems
05.2025 - Current
Skills
- Regulatory Strategy
- Documentation
- Submissions
- Veeva RIMS
- Data Management
- CMC Review
- Data & Analytics
- Advanced Excel
- Pivot
- VLOOKUP
- Text functions
Team leadership & development
Client relationships
Processes and procedures
Education Certifications
- Executive PG certification in International Drug Regulatory Affairs, 05/25, ongoing
- Veeva RIMS certification by Veeva Vault, 05/25, ongoing
- Attempted RAC (US), 2015 and 2018 May, 65 percentiles, not certified.
Training
- Lean Six Sigma Certified, 2023, Genpact
- Generative AI training, 2024, 2025 Beginner and Intermediate Level, Genpact
- Corporate Women Leadership Training, Aug- Dec 2018, TISS, through Iron Lady
Achievements Recognitions
- 4x Cheers Awards for project excellence & CSR initiatives (Genpact)
- Received client appreciations from US JV partner - Sagent pharmaceuticals (Agila)
- Recognized for quick learning & quality delivery (Sciformix)
- Selected as a support for external API firm audits (Torrent)
Timeline
Discover Veeva RIM Certification - Veeva Vault
Veeva Systems
05.2025 - Current
Lead Consultant (Assistant Manager)
Genpact India Pvt. Ltd.
02.2021 - Current
Team Leader, Regulatory Affairs
Apotex Research Pvt. Ltd.
10.2015 - 06.2016
Sr. Regulatory Affairs Specialist
Sciformix Tech. Pvt. Ltd.
11.2014 - 10.2015
Senior Executive, Regulatory Affairs
Agila Specialties Pvt. Ltd.
02.2010 - 10.2014
Junior Manager, Development QA
Dr. Reddy's Laboratories
07.2007 - 08.2008
Scientist II, R&D QA
Torrent Research Centre
05.2005 - 06.2007
M. Pharma - undefined
Al- Ameen College of Pharmacy
01.2003 - 01.2005
Certification Program - Regulatory Affairs
International Drug Regulatory Affairs
04.2001 - Current
B. Pharma -
Shree Siddaganga College of Pharmacy
01.1998 - 01.2002
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