Dilipkumar Suryawanshi

About Dilipkumar Suryawanshi

Passionate and Result oriented Global Regulatory Affairs Professional with a wide…

Experience

1. Associate Manager -i Reg Cmc Strategy, Sterile Injectables Lcm (Global Regulatory Affairs)

   화이자

   Jan 2023 — Present · Mumbai, IN

   Responsibilities: • Functions as the Regulatory Strategist for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia, New Zealand and other developing markets.• Responsible for the execution of finalized Regulatory Strategy through compilation of CTD sections for supplements/variations while ensuring effective data presentation and quality. • Also provides guidance and support to Junior Regulatory Strategists in the preparation of quality supplements/variations.• Responsible for effective coordination with the Global RA teams for the review and finalization of supplements/variations to ensure effective data presentation and quality. • Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (batch records, Exhibit batch and stability protocol).• Provides regulatory assessment and supports Change Control Assessment. • Provide regulatory support for the assigned projects, participates and provides inputs in technical reviews and strategic discussions on LCM submissions and Change Control reviews, as assigned. • Identifies and assesses regulatory risks associated with assigned projects and ensures timely communication to the team to quickly mitigate the risks.• Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, team lead and core team. • Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.• Responsible for ensuring compliance to Company’s submission standards, policies and procedures.