Poornima Sane

Strategic Regulatory Affairs Professional with extensive experience in identifying regulatory submission gaps and implementing compliance solutions. Drives organizational success through analytics and cost-benefit analysis while fostering teamwork and collaboration. Mentors junior staff to enhance performance and close knowledge gaps, promoting growth and a positive corporate image.

REGULATORY AFFAIRS EXECUTIVE - Mehta API Private Limited - Andheri, Mumbai

(2025-03)

• Facilitated preparation, review, and maintenance of drug master files (DMFs) to ensure regulatory compliance.
• Compiled and submitted new DMF/ASMF/CEP to health agencies including US, Europe, EDQM, and ROW.
• Reviewed pre-filling documents [TTD / Process / Specifications / Validations / Stability ext.] for new DMF/CEP submissions, ensuring adherence to regulatory specifications.
• Coordinated post-approval amendments for DMF/ASMF/CEP, meeting submission timelines for annual reports.
• Provided regulatory support and guidance to manufacturing sites during health authority audits.
• Identified gaps in regulatory submission documents, collaborating with departments to enhance quality and compliance.
• Managed cross-departmental projects to enhance operational efficiency.
• Issued Letters of Authorization (LOAs), including CEP LOAs, to customers and regulatory authorities.

QA/RA EXECUTIVE - Vama Lifecare Private Limited - Lower Parel, Mumbai

(2023-11 - 2025-02)

• Processed vendor approval requests by completing forms, questionnaires, and sharing FAQs and necessary documents.
• Handling regulatory requests / queries from customers.
• Maintenance of regulatory documentation in electronic format and saving key communication.
• Reviewed and identified gaps in regulatory submission documents, discussed findings with relevant departments, and provided suggestions aligned with current regulatory guidelines.
• Coordinated with marketing department to ensure compliance with customer and health agency requirements.

QC SENIOR EXECUTIVE - Samrudh Pharmaceutical Private Limited - Boisar, Palghar

(2020-03 - 2023-11)

• Sample storage and management (FDF & API), Analytical testing, documentation of drug product, finished product, complaints, stability, packaging material samples to GxP standards
• Assisting supervisor Quality Control for efficient functioning of Quality Control Laboratory through QC analysis and good documentation as per quality control system
• Stability Testing, Sample storage and management

PGD IN REGULATORY AFFAIRS - Formulation +API - IPM, in BORIVALI (2024-07)

MASTER’S DEGREE IN SCIENCE - Analytical Chemistry - The Wilson College, Chowpatty (2017 - 2019)

CERTIFICATE - PGD in Clinical Research (2016)