Vishal Dhanawade

About Vishal Dhanawade

Transformational Regulatory Affairs Leader | 15+ Years of Expertise in Global Regulatory…

Experience

1. Manager -regulatory Affairs & Business Continuity

   SUN PHARMA

   Feb 2022 — Present

   Involved in the development and execution of regulatory strategies for US and OAM new submissions & life cycle management submissions.• Provided regulatory guidance and assistance during product development, including formulation, analytical, and clinical stages.• Compiled and reviewed dossiers (Modules 1–5) for submissions in US, European, and Canadian markets and responded to deficiencies to secure timely approval.• Managed post-approval changes for products in US, Europe, Australia, and Canada markets, including management of lifecycle submissions for the US: Annual Reports (AR), Changes Being Effected (CBE-0, CBE-30), and Prior Approval Supplements (PAS), For Europe: Type IA, IB, and II variations; for Australia: notifications and Category 3 changes; for Canada: Level 1 and Level 2 changes• Managed and responded to FDA queries, deficiencies, and communication requests received from authorities.• Conducted change assessments and change control management, Via the Trackwise System, defined regulatory strategies, prepared submission packages, and tracked regulatory submissions.• Communicated changes to internal stakeholders (e.g, manufacturing, quality) and external stakeholders (e.g, FDA, customers).• Supported business continuity activities through coordination with various stakeholders.• Ensured regulatory compliance from product development to commercialization.• Coordinated and collaborated with cross-functional teams in R&D, project management, manufacturing locations, 3rd party contract manufacturers, and other relevant stakeholders.• Clearly communicated regulatory requirements to stakeholders.• Provided on-the-job training to subordinates and an overview of their activities.• Kept updated with current regulatory guidance documents and requirements.• Led development and implementation of RIMS-Amplexor for departmental functions extension to eCTD submissions and electronic labeling.

Skills

• Regulatory Affairs
• Life Sciences
• Pharmaceutical Industry
• Sop
• Validation
• Gmp
• Quality Assurance
• Pharmaceutics
• Anda
• Glp
• Technology Transfer