Summary
Overview
Work History
Education
Skills
Certification
Training
Accomplishments
Websites
Timeline
Generic

Prathibha H Gowda

Bangalore

Summary

Seasoned Drug Regulatory Affairs professional with 14.5 years of experience in the pharmaceutical industry with proven expertise in handling dossier submissions, compliance audits, regulatory data management, and stakeholder management, with good analytical skills, a strong focus on business process optimization, efficiency, and quality.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Lead Consultant (Assistant Manager)

Genpact India Pvt. Ltd.
Remote
02.2021 - Current
  • Proposed regulatory filing strategies and authored CMC sections for global variations including US, EU, and Asian markets.
  • Developed work procedures for initial MA registration in Veeva Vault across multiple global markets.
  • Managed end-to-end RIMS data migration activities involving data analysis, cleansing, enrichment, and quality control reviews.
  • Leveraged advanced Excel techniques for data optimization and reporting efficiency.
  • Utilized industry expertise and analytical skills to address customer concerns effectively.

Team Leader, Regulatory Affairs

Apotex Research Pvt. Ltd.
Bangalore
10.2015 - 06.2016
  • Managed submission of 30 + high-priority ANDA data integrity (DI) reports for US FDA inspection clearance.
  • Facilitated communication across Apotex Canada, U.S. and India teams for regulatory compliance for ANDAs.

Sr. Regulatory Affairs Specialist

Sciformix Tech. Pvt. Ltd.
Pune
11.2014 - 10.2015
  • Led ANDA Data Integrity (DI) project
  • Facilitated scientific writing for EU regulatory submissions (Module II reports).
  • Conducted a walk-in drive; interviewed 30+ candidates in a recruitment drive.

Senior Executive, Regulatory Affairs

Agila Specialties Pvt. Ltd.
Bangalore
02.2010 - 10.2014
  • Managed the submission of 20+ ANDAs for injectable drug products.
  • Oversaw the submission of post-approval supplements (PAS, CBE-30). Was responsible for 50+ annual reports and 15+ PADER submissions.
  • SPOC for a U.S. joint venture company
  • Maintained positive customer relations by addressing problems head-on and implemented successful corrective actions.
  • Defined clear targets and objectives and communicates to team members.

Junior Manager, Development QA

Dr. Reddy’s Laboratories
07.2007 - 08.2008
  • Implemented QbD principles and conducted routine internal audits as to ensure process compliance as per defined QbD.
  • Reviewed & approved CMC regulatory documents (development, specifications, executed batch records) for global regulatory submissions.
  • Applied FMEA for Risk management of R & D Process

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 CMC regulatory documents (development, specifications, executed batch records) for global regulatory submissions.

Education

B. Pharma -

Shree Siddaganga College of Pharmacy
Bangalore

M. Pharma -

Al- Ameen College of Pharmacy
Bangalore

Skills

  • ANDA Submissions
  • Regulatory Strategies
  • CMC
  • Post-Approval SubmissionsMicrobiology
  • Labelling
  • Regulatory compliance
  • Project management
  • Data analysis
  • Veeva Vault
  • Customer service
  • Team leadership
  • Problem solving
  • Product life cycle management
  • Annual Reports
  • PADERs
  • Variations Submissions
  • Veeva Regulatory Information Management Systems
  • RIMS Migration
  • Scientific Writing
  • EMA Registration Procedures
  • Regulatory Tools
  • Quality & Compliance
  • Project Management
  • Data & Analytics
  • Advanced Excel

Certification

  • Executive PG certification in International Drug Regulatory Affairs by Royed Training Services
  • Veeva RIM certification by Veeva Systems

Training

  • Lean Six Sigma Certified, 2023, Genpact
  • Generative AI training, 2024, 2025, Beginner and Intermediate Level, Genpact

Accomplishments

  • 4x Cheers Awards for project excellence and CSR initiatives (Genpact)
  • Received client appreciations from US JV partner, Sagent Pharmaceuticals (Agila)
  • Recognized for quick learning and quality delivery (Sciformix)
  • Selected for external API audits alongside GM, Torrent

Timeline

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

B. Pharma -

Shree Siddaganga College of Pharmacy

M. Pharma -

Al- Ameen College of Pharmacy

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Prathibha H Gowda