manager regulatory affairs at teva pharmaceuticals@ Merck
Horsham, Pennsylvania, United States
Vishal Patel
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Rajiv Gandhi University of Health Sciences
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FlashIntel GPTVishal Patel is an experienced regulatory affairs professional with 18.8 years of work experience in the pharmaceutical industry. He has expertise in CMC regulatory affairs, FDA regulations, and regulatory submissions. Vishal has worked at Merck and Merck in various roles, including Manager Regulatory Affairs and Senior Regulatory Affairs Associate. He has a strong understanding of FDA regulations and FDA regulations. Vishal is currently based in Horsham, Pennsylvania.
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About
- 13+ years of experience in CMC regulatory affairs - 4 years of experience in labeling submissions and publishing submission in eCTD format - Prepare, review, and submit ANDAs, NDA 505(b)(2)s, Amendments, Post approval supplements (PAS, CBE-30, CBE-0), and Annual Reports of Generic Drug Products - Understanding of OTC FDA regulations - Understanding of 510(k) FDA regulations
Work Experience
manager regulatory affairs at teva pharmaceuticals
Pharmaceutical Manufacturing
Vishal Patel's Professional Milestones
- Sr. Regulatory Affairs Associate (2013-01-01~2017-09-01): Streamlined regulatory processes, enabling improved efficiency and compliance.
- Senior Regulatory Affairs Associate (2013-01-01~2017-09-01): Successfully navigated complex regulatory landscape, ensuring compliance and ensuring company growth.
Education
Pharmacy
946684800-1072915200Skill
Regulatory Affairs
Pharmaceutical Industry
Ectd
Anda
Regulatory Submissions
Gmp
Validation
Sop
Regulatory Requirements
Pharmaceutics
Technology Transfer
Generic Programming
Change Control
Dissolution
Ind
21 Cfr Part 11
Cmc
Pharmacovigilance
Standard Operating Procedure
Ctd
Regulatory Documentation
Certification
Colleagues
Shawn S.
biologist at merck game developer business owner
Bogdan Nicoara
Product Owner
Nicole Barone
Sr Business Analyst/Product Owner at Merck
Tom McCallister
sap business process owner at jacklinks
Jay Pernikoff
IT Service Delivery Management | Problem Service Owner Manager | Project Management | Production Management
Other Named Vishal Patel
Frequently asked questions
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Vishal Patel's social media include: Linkedin,
Vishal Patel works for Merck
Vishal Patel's role in Merck is manager regulatory affairs at teva pharmaceuticals
Vishal Patel works in the industry of Pharmaceutical Manufacturing
Vishal Patel's colleagues are Shawn S.,Bogdan Nicoara,Nicole Barone
Vishal Patel's latest job experience is manager regulatory affairs at teva pharmaceuticals at Merck
Vishal Patel's latest education in Rajiv Gandhi University of Health Sciences
