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 -