Ramandeep Kaur
Director, Global Regulatory Affairs Services @Syneos Health
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WORK HISTORY
Director, Global Regulatory Affairs Services @Syneos Health
CA
EDUCATION
Guru Nanak Dev University
B Pharmacy, Pharmacy
Panjab University
M. Pharm, Pharmaceuticals
SKILLS
ABOUT RAMANDEEP KAUR
I have 18 years of experience in the field of Regulatory Affairs and CMC supporting the product life cycle of new chemical entities, biologicals, generics, and biosimilars. I have recently been involved in CMC authoring of submissions for cell and gene therapy based products.I have extensively worked on the development of regulatory submission strategies, planning, authoring, review, and tracking of submissions. I have worked on global projects and have a thorough understanding of regulations and guidelines of US, Canada, EU, Australia and Rest of the World markets. I have successfully supported the submission and approval of IND/CTAs, NDAs/MAAs, post-approval supplements/variations, license renewals, annual reports and responses to questions from Health Authorities.My career has led me to specialize increasingly in the management of both regulatory and CMC aspects of complex global projects, which I can readily apply to any position that requires such an expertise.
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