Patil Sujata
Regulatory Affairs Professional (ROW | Europe)
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About
Detail-oriented Regulatory Affairs professional with 2+ years of experience in pharmaceutical regulatory operations across ROW (Africa & emerging markets). Skilled in CTD/ACTD/eCTD dossier preparation, product registration, renewals, variations, and post-approval lifecycle management. Strong working knowledge of WHO, ICH guidelines and global regulatory standards, with proven ability to support multi-country submissions, regulatory intelligence, compliance documentation, and authority interactions.
Experienced in cross-functional coordination with QA, QC, Production, and R&D, ensuring timely approvals, audit readiness, and regulatory compliance. Seeking opportunities in high-growth pharmaceutical companies across India, GCC (UAE, Saudi Arabia, Qatar), and Europe.
Experience
Senior Officer – Regulatory Affairs - S Kant Healthcare Ltd. - Navi Mumbai, India
(2025-10)
- Lead preparation, review, and submission of regulatory dossiers (CTD/ACTD/eCTD) for product approvals, renewals, and variations
- Coordinate cross-functional teams to ensure timely, compliant, and high-quality submissions
- Monitor regulatory updates and implement changes aligned with WHO / ICH guidelines
- Support regulatory audits and inspections, ensuring documentation readiness and compliance
- Maintain regulatory databases and submission tracking systems for lifecycle management
Regulatory Affairs Executive - Lexine Technochem Pvt. Ltd. - Vadodara, India
(2024-07 - 2025-10)
- Managed multi-product regulatory submissions across ROW markets, ensuring timely approvals
- Supported product registration strategies and lifecycle management planning
- Handled post-approval changes including variations, labeling updates, and annual reporting
- Coordinated responses to health authority queries and deficiency letters
- Ensured compliance with internal QMS and international regulatory requirements
Business Analyst - Shree Ram Engineering & Contractor - Surat, India
(2023-09 - 2024-06)
- Performed data analysis and reporting to support operational and business decision-making
- Developed structured reports for project tracking and client communication
Education
MBA - Data Science & Business Analytics (2026-01)
Bachelor of Pharmacy - B.Pharm - Gujarat Technological University (SNLPCP) (2024)
HSC - GSEB (2020)
SSC - GSEB (2018)
