Samir Phulari
Head - Global Submission Management at Novartis Healthcare Pvt Ltd
- Role
- Head - Global Submission Management - Novartis Regulatory Affairs at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Samir Phulari
A senior leadership position in Novartis Regulatory Affairs - Operations accountable for leading a multi-dimensional team of Submission Managers, Submission Publishers and Submission Resource Planners (across regions and globally) in support of worldwide regulatory submissions across NVS global product portfolios* Lead and deliver high quality submissions (electronic,nees and/or paper) to Health Authorities worldwide(EMA, FDA, Swissmedic, RoW)• Technical Format Expert at Health Authority and key business meetings• Key role in finalization and timely delivery of regulatory submissions to different Health Authorities • Provide advice and guidance to project teams regarding general content and format of regulatory submissions• Partners the Global Therapy Area Leads and liaises closely with DRA managers in order to incorporate Health Authority requirements• Provide strategic and operational expertise to project teams to ensure the timely preparation of submission critical documents• Share expertise within the company through training, education & knowledge transfer.
Experience
Head - Global Submission Management - Novartis Regulatory Affairs
Apr 2016 — Present
Education
Shri Bhagwan College of Pharmacy, Aurangabad
Bachelor's Degree, Pharmacy
1999 — 2003
J.S.S. College of Pharmacy, Ooty
Master's Degree, Pharmaceutical Biotechnology
2003 — 2005
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