Mr. Subhash Patil is a seasoned professional in the pharmaceutical industry with over 15 years of expertise in regulatory affairs, project management, and quality management systems. His career has been dedicated to ensuring global regulatory compliance, accelerating product approvals, and supporting innovative pharmaceutical development.

Currently, he serves as Deputy General Manager – Head of Regulatory Affairs at Gufic Biosciences Limited, Mumbai (since Nov 2024). He has previously held senior regulatory leadership roles in reputed pharmaceutical companies, including Indoco Remedies, Centaur Pharmaceuticals, Bharat Serums and Vaccines, Alembic Pharmaceuticals, Zydus Cadila, and Apotex Research Pvt. Ltd. His experience spans across regulated markets (US, EU, Canada, Australia, Brazil) as well as Rest of World (ROW) territories.

Regulatory Expertise & Contributions

• Skilled in managing regulatory submissions for parenteral dosage forms, ensuring compliance with stringent regulatory requirements.

• Successfully developed and implemented regulatory strategies for both new product development and lifecycle management.

• Experienced in Drug Master File (DMF) submissions for EU and ROW markets and customer coordination for timely approvals.

• Expertise in regulatory project management, team leadership, and compliance monitoring.

• Proficient in supporting QMS activities and managing health authority inspections to maintain regulatory excellence.

Research & Innovation

• Filed a patent specification with the Indian Patent Office for a Pharmaceutical Composition for Extended Release, reflecting his contribution to pharmaceutical innovation and formulation science.

• Consistently monitored regulatory guidance updates to align product strategies with evolving scientific and compliance requirements.

Certifications & Training

Mr. Patil has enhanced his expertise through globally recognized certifications, including:

• ISO 9001:2015 Lead Auditor – Quality Management System (IRCLASS, 2022)

• Project Management Professional (PMP®) – Project Management Institute (2021)

• Executive Management Development Programme in Project Management – Indian Institute of Management, Kozhikode (2021)

Awards & Recognitions

• Zydus-Kshitij Award for regulatory support in developing complex products and achieving annual ANDA submission targets.

• Apotex Best Service Award for successfully meeting regulatory submission goals.

Leadership & Global Impact

Mr. Patil has demonstrated strong leadership in guiding regulatory teams, setting submission goals, and driving progress to ensure timely product approvals and commercial launches. His ability to navigate complex international regulatory frameworks has significantly contributed to the global availability of safe and effective medicines.

Eligibility for Emerging Scientist Award

With his extensive regulatory expertise, patent contribution, leadership in global pharmaceutical submissions, and recognized professional achievements, Mr. Subhash Patil embodies the qualities of an innovative and impactful scientific professional. His combination of regulatory acumen, research contribution, and leadership makes him highly deserving of the Emerging Scientist Award in Scientific Laurels.