Anuya Aras
Regulatory Consultant @Orphix Consulting Gmbh
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WORK HISTORY
Regulatory Consultant @Orphix Consulting Gmbh
Munich, DE
Project Lead for multiple projects including MAAs, Compassionate Use Programs (CUP), EU Orphan Drug Designations (ODD), EU & UK Pediatric Investigation Plans (PIP), Scientific Advices, EU and UK Variations• Budget management and business development as a part of Project Lead role• Strong experience in CMC Regulatory, US and EU Regulatory Strategy support and preparing for Agency interactions• Preparing regulatory submissions including Pre-MA procedures, INDs, BLAs, NDAs, MAAs, variations, renewals and MA Transfers• Managing regulatory submissions and procedures including SAs, CTAs, PIPs, ODDs, CUPs in EU and UK
EDUCATION
Poona college of pharmacy
Master of pharmacy, Pharmacology and Toxicology
Goa college of pharmacy
Bachelor of Pharmacy (BPharm)
Hochschule für Technik und Wirtschaft Berlin
Master of Business Administration - MBA, Life science management
SKILLS
ABOUT ANUYA ARAS
A highly motivated regulatory professional with over 6 years experience in the Regulatory industry. Experience supporting projects ranging across the entire product lifecycle from development through to variations. Holds B. Pharm, M. Pharm and MBA degrees. Excellent communication skills and experience with EMA, FDA and National HAs.
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