Senior Manager, Regulatory Affairs –Biosimilars Lead, EU
Reading, United Kingdom
Dr. Ruchi Singh is a regulatory professional with a proven track record of developing and delivering effective regulatory strategies for key emerging markets. She has a strong CMC background due to her detailed experience in research and development in the field of biologics and gene therapy. She has demonstrated leadership for emerging market regulatory strategy for high...
Dr. Ruchi Singh is a regulatory professional with a proven track record of developing and delivering effective regulatory strategies for key emerging markets. She has a strong CMC background due to her detailed experience in research and development in the field of biologics and gene therapy. She has demonstrated leadership for emerging market regulatory strategy for high profile biologic products, resulting in the development of regulatory filing plans which support numerous submissions in a number of markets worldwide. She is responsible for providing regulatory knowledge and support for submissions for emerging markets including Asia and Latin America. She has attended Health Agency meetings in key emerging markets such as India (DCGI) and Singapore (HSA). She has experience in running collaboration projects with responsibilities ranging from planning and execution to final delivery of results including project management and SOP compliances. This includes team management (effort/task allocation and time management) and project budgeting and financials. Dr. Singh has presented RAPS Webinar on Biosimilars and ATMPs – Current Developments in India. She has also published opinions in a reputed industry magazine (SCRIP Regulatory) on recently released Indian Biosimilar guidelines.Regulatory Affairs Manager @ From November 2012 to Present (3 years) Associate Consultant @ From August 2011 to October 2012 (1 year 3 months) Senior Scientist @ From October 2007 to August 2011 (3 years 11 months) Senior Scientist @ From August 2006 to September 2007 (1 year 2 months) PhD @ Delhi University From 2000 to 2005 St.Mary's Convent School, Ghazipur Ruchi Singh is skilled in: Lifesciences, Technology Transfer, Drug Discovery, Biotechnology, Pharmaceutical Industry, Drug Development, Regulatory Affairs, Clinical Trials, Regulatory Submissions, Clinical Development, Biopharmaceuticals, Drug Delivery, Biologics, CMC, Regulatory Requirements, IND, Sop, Oncology, Life Sciences, SOP
What company does Ruchi Singh work for?
Ruchi Singh works for Biogen Idec
What is Ruchi Singh's role at Biogen Idec?
Ruchi Singh is Regulatory Affairs Manager
What industry does Ruchi Singh work in?
Ruchi Singh works in the Pharmaceuticals industry.
Who are Ruchi Singh's colleagues?
Ruchi Singh's colleagues are Jason Turns, Trudy Goode, Jeffrey CBSP, Laura Ph.D., Terri Craig, Christopher Eliopulos, Paul Gaylord, Annlouise Assaf, Tony Marchese, and Nele Vandekerckhove
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