Patil Sujata

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.

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

MBA - Data Science & Business Analytics (2026-01)

Bachelor of Pharmacy - B.Pharm - Gujarat Technological University (SNLPCP) (2024)

HSC - GSEB (2020)

SSC - GSEB (2018)