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Sneha Patel

@snehapatel4

Global Regulatory Affairs consultant who established European Marketing Authorization setup and guides complex generic filings.

India

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At SIA Global Lux, I provided regulatory strategy for product development and established Marketing Authorization setup for European filings. I also handled global filing operations for complex generics developed through CDMOs and CMOs.

At Piramal Enterprises, I led a team of four managing the EU lifecycle of critical care products, including inhalation anesthetics, solid orals, and parenteral dosage forms. I managed submissions, variations, renewals, and DMFs for in-house APIs.

Earlier, at Tevapharm India Pvt Ltd, I led a team handling 160 EU procedures, including submissions, variations, and lifecycle management. My work spans global regulatory submissions, dossier preparation, lifecycle management, and health authority interactions.

Experience

Work history, roles, and key accomplishments

Consultant – Global Regulatory Affairs

SIA Global Lux

Jun 2025 - Apr 2026 (10 months)

Provided regulatory strategy during product development to prepare globally compliant dossiers. Established Marketing Authorization setup for Europe filings and led regulatory operations for global filings across regulated and semi-regulated markets.

Regulatory Strategy Dossier Preparation Marketing Authorization Global MAA Submissions Complex Generics CDMO CMO

Regulatory Consultant

Olpha

Apr 2024 - Jun 2025 (1 year 2 months)

Led end-to-end regulatory operations for global filings across EU and ROW markets. Managed submission strategies, dossier compilation, and lifecycle activities for complex generic products.

Regulatory Operations EU CTR Submissions ROW Submissions Dossier Compilation Lifecycle Management Oncology Cardiovascular

Chief Manager – Regulatory Affairs

Piramal Enterprises

May 2019 - Apr 2024 (4 years 11 months)

Led a team of 4 managing lifecycle of critical care product portfolio for EU markets. Managed regulatory submissions, variations, renewals, and compliance activities ensuring timely approvals and market continuity.

Regulatory Affairs Lifecycle Management EU CTR Submissions DMF Compilation Team Leadership Cross functional Coordination

Senior Regulatory Affairs Officer (Global Regulatory Lead – CMC)

IQVIA

May 2018 - May 2019 (1 year)

Managed CMC regulatory submissions for small molecules and biologics across Europe and ROW markets. Prepared and reviewed technical documentation ensuring compliance with international regulatory standards.

Regulatory Submissions Small Molecule Biologics Europe ROW Technical Documentation

Manager (Group Leader) – Regulatory Affairs

Tevapharm India Pvt Ltd

Mar 2012 - Apr 2018 (6 years 1 month)

Led a team of 11 handling regulatory activities for 160 EU procedures including submissions, variations, and lifecycle management. Ensured compliance with EU regulatory requirements and successful execution of multiple regulatory projects.

Regulatory Affairs EU Procedures Submissions Variants Lifecycle Management Team Leadership

Scientist II – International Drug Regulatory Affairs

Torrent Research Centre

Oct 2007 - Apr 2008 (6 months)

Compiled CTD sections for ASMF and finished product dossiers as per EU regulatory requirements. Supported dossier preparation for multiple international submissions.

CTD ASMF Dossier Preparation Regulatory Requirements