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