Overview
Work History
Education
Skills
Skills
Timeline
Generic

Gayatri Rane

Mumbai

Overview

4
4
years of professional experience

Work History

Regulatory Affairs Officer

Lupin Limited
11.2021 - Current
  • Prepared and submitted Drug Master Files (DMFs) for active pharmaceutical ingredients (APIs) in alignment with global regulatory requirements, including US FDA, EMA, WHO, ANVISA, and TGA.
  • Specialized in WHO DMF submissions, ensuring completeness, data accuracy, and timely regulatory approvals for international markets.
  • Managed lifecycle maintenance of DMFs including amendments, deficiency responses, and annual updates in coordination with internal stakeholders and regulatory authorities.
  • Conducted regulatory submissions across emerging and regulated markets: Brazil (ANVISA), Europe, US, Canada, Switzerland, Korea, Saudi Arabia, Kenya, Australia (TGA), and WHO PQ programs.
  • Compiled, reviewed, and published eCTD dossiers using Educe Dossier Management System, ensuring compliance with ICH CTD structure and country-specific submission formats.
  • Prepared both Applicant’s Part (Open Part) and Restricted Part (Closed Part) of DMFs per agency and client requirements.
  • Issued and coordinated regulatory documents such as Certificates of Suitability (CEP), Letters of Access, and Letters of Commitment to support client and regulatory agency submissions.
  • Maintained and updated regulatory information management systems (RIMS) and submission tracking databases for compliance monitoring and audit readiness.
  • Participated in internal audits, regulatory inspections, and cross-functional meetings with QA, QC, Manufacturing, and R&D to align regulatory strategy and documentation.
  • Completed ongoing GxP training, ICH guidelines updates, and internal e-learning modules to stay current with regulatory affairs best practices.

Education

Post Graduation - Data Science And Business Analytics

Great Learning - Great Leaks Institute of Management
Mumbai
04.2001 -

Post Graduate Diploma in Regulatory - In API & Formulation

Institute Of Pharmaceutical Management
Mumbai
04.2001 -

Master of Science - Organic Chemistry

Ramnarain Ruia Autonomous College
Mumbai
04.2001 -

Bachelor of Science - Chemistry

Vidyavardhini’s Annasaheb Vartak College
Mumbai
04.2001 -

Skills

  • Python

  • SQL

  • TABLEAU

  • KNIME

  • Data Visualization

  • Data Preprocessing

  • Statistical Methods for Decision Making

  • Optimization techniques

  • Linear programming

  • Goal programming

  • Integer programming

  • Non-linear programming

  • Predictive Modelling

Skills

  • Microsoft Excel
  • Microsoft Word
  • Microsoft PowerPoint

Timeline

Regulatory Affairs Officer

Lupin Limited
11.2021 - Current

Post Graduation - Data Science And Business Analytics

Great Learning - Great Leaks Institute of Management
04.2001 -

Post Graduate Diploma in Regulatory - In API & Formulation

Institute Of Pharmaceutical Management
04.2001 -

Master of Science - Organic Chemistry

Ramnarain Ruia Autonomous College
04.2001 -

Bachelor of Science - Chemistry

Vidyavardhini’s Annasaheb Vartak College
04.2001 -
Gayatri Rane