Ashish Wadhwani

Project Manager - Drug Regulatory Affairs

Role: Project Manager - Drug Regulatory Affairs at Freyr Solutions
Location: Nagpur, MH, IN
LinkedIn followers: 500 followers

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About Ashish Wadhwani

Accomplished Project Manager with 9+ years in Drug Regulatory Affairs, excelling in…

Experience

Project Manager - Drug Regulatory Affairs
Freyr Solutions
Sep 2023 — Present · IN
Responsible for the oversight of Gastro-intestinal & Inflammatory (GI & I) portfolio drugs for liver, blood platelet, and chronic kidney related disease currently in the late development phase (Phase 3) – Managing end-to-end submissions for US.Stakeholder Management: Identified and collaborated with stakeholders, including Global Regulatory Leads and Regional Leads for the US, EU, China, Japan, and Emerging Markets, to ensure successful submission initiation, planning, execution, and completion.Project Communications & Collaboration: Streamlined communications to overcome coordination challenges and facilitated consensus to ensure timely document delivery, enhancing submission efficiency.Risk Analysis & Management: Created and maintained a Risk Register in collaboration with regional leads to address project bottlenecks and develop mitigation and contingency plans.Timeline Development & Management: Developed synchronized timelines for over 50 global product markets using MS Project, ThinkCell, One pager Pro, and Office Timeline Plus for expected product launches.Process Improvement: Identified gaps in the submission process, reducing processing and delivery times by nearly 30%, and streamlined document archival for agency correspondences in Veeva.Regulatory Project Plan Creation & Maintenance: Managed global submission details in regulatory project plans to align with regional product launch strategies.Submissions Management: Negotiated submission timelines, identified regional requirements, and built and reviewed submissions using DocuBridge to ensure regulatory compliance.Project Leadership: Initiated and led over 6 project kick-offs, 10 SWGs, and multiple RRT meetings, capturing key decisions and action items to drive accountability and progress.Special Designations: Co-ordinated BTD, ODD, and Fast Track for the US, Europe, China, and Japan.PIP, PSP, and CTA: Coordinated timelines for PIPs and CTAs in Europe and PSP in the US for various portfolio drugs.

Education

J.L chaturvedi College of Pharamacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2012 — 2015
NMIMS CDOE
Diploma of Education, Business Administration and Management, General

Skills

Clinical Research
Sql
Submission Publishing
Business Analysis
Microsoft Office
Management
Requirements Analysis
Microsoft Excel
Powerpoint
Regulatory Affairs
Customer Service
Project Management
Regulatory Submissions
Leadership

Contact information

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Current company

Razorpay

Software Development · 4K employees · Bangalore, Karnataka, India

Power your finance, grow your business. Razorpay is India’s first full-stack financial solutions company. We are on a mission to enhance the payment experience of over 300 million end consumers. And in doing so, we aim to enable Indian businesses - big and small - accept payments digitally with minimal effort and maximum ease. Razorpay has grown from being a payment gateway provider to a solutions-driven organization boasting of an extensive products suite to accept and disburse payments as well as raise capital and park money. In a nutshell, we fit into every nook and corner where your business touches money. #OutgrowOrdinary We identify ourselves as disruptors in the digital payments space and our vision is to power the financial ecosystem for other disruptors. Like attracts like and Razorpay actively looks to partner with established companies and startups that have either broken the glass ceiling in their industry or are set to. The Razorpay Product Suite today comprises verticals, along with Payment Gateway, like Payment Links, Payment Pages, Subscriptions, Smart Collect, Route, Razorpay Capital, RazorpayX, Payroll and Thirdwatch. Razorpay was started in 2014 by two IIT Roorkee alumni, Harshil Mathur and Shashank Kumar. Just a short few years later, Razorpay has evolved into a 800-odd strong organization with some of the best talents in the country helping some of the best companies manage their money movement seamlessly. Certified cool We are a bunch of spirited, ambitious and fun folks. And no, we’re not saying this ourselves--leading institutions have recognized Razorpay for the high trust and high-performance culture that we maintain. Our strength lies in the people we are and we go to great lengths to nurture a family of coders, designers, sellers, marketers, analysts, writers, runners, photographers, gamers, tinkerers, and above all, people who are dreamers and doers at the same time. Be a part of our exciting journey.

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