Ruchi Singh

Director Global Regulatory Affairs @Pfizer

Reading, GB
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Dec 2019 — Present

Director Global Regulatory Affairs @Pfizer

View department →

GB

EDUCATION

2000 — 2005

Delhi University in collaboration with Johns Hopkins, Singapore

PhD, Nanoparticles and its applications in gene therapy

SKILLS

BiotechnologyStandard Operating Procedure (Sop)Drug DeliveryClinical TrialsRegulatory AffairsLifesciencesProject PlanningCell TherapyClinical DevelopmentRegulatory SubmissionsLife SciencesPharmaceutical IndustrySopDrug DiscoveryTechnology TransferRegulatory RequirementsIndOncologyDrug DevelopmentCmcBiopharmaceuticalsBiologics

ABOUT RUCHI SINGH

Dr. Ruchi Singh is a regulatory professional with a proven track record of developing and delivering effective regulatory strategies for EU and key emerging markets. She has demonstrated leadership for EU and 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 EU and emerging markets including Asia and Latin America. She has led Health Agency meetings in the EU and 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.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Ruchi Singh — Director Global Regulatory Affairs at Pfizer in Reading, GB | Unifers