Safan Sunesara
Independent Consultant @Lonza
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WORK HISTORY
Independent Consultant @Lonza
EDUCATION
University of Mumbai
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
Houston City College
Associate of Science (A.S.), Selected Courses: Statistics, Genetics, Advance Physics, Calculus and Public Speaking.
Cosmopolitan College of Science
Associate of Science (A.S.), Pre-Pharmacy Studies
Northeastern University
Master of Science in Regulatory Affairs for Drugs, Biologic and Medical devices, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
SKILLS
ABOUT SAFAN SUNESARA
An individual with expertise in pharmaceutical sciences as well as armed regulatory competency in US, EU, CIS and Asian countries. Professional and academic triumphs are hugely contributed towards my perceptive behavior as a strategy developer, information hunter, and connected team player. Prioritizing opportunities and landing to potential avenues through networking and self advocacy has pioneered me to this stage. I believe in direct approach and openness in assisting my coworkers to improve existing work processes for maximum productivity. Seeking the most robust, least burdensome and sound regulatory solutions for my firm within the preset bounds makes me a “Regulatory Affairs Specialist”.Specialties:IND/NDA/ANDA/CTA/BLA/MAA SubmissionsDMFs, 510k, IDE, PMA, EU Technical Files SubmissionsMedical Device Regulations – USA, CanadaPharmacovigilance Reporting: PSURs, Spontaneous ADEs & 15-Day Alert ReportsExport Certificates- CPP, CFG,GXPs Compliance and AuditingClinical Protocols for Phase I and Phase II trials & TMFLabeling Review, OPDP Submissions & SPL Regulatory strategy pertaining regulations and amendments
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