Prerna Khandelwal
Senior Manager, Global Regulatory Strategy @AbbVie
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WORK HISTORY
Senior Manager, Global Regulatory Strategy @AbbVie
EDUCATION
Meerut University
Organic Chemistry
SKILLS
ABOUT PRERNA KHANDELWAL
Accomplished Professional with over 18 years of experience in Regulatory Affairs and Pharmacokinetic and Drug Metabolism (PKDM) in biotechnology industry. Specialize in wide range of regulatory eCTD Submissions and Project Management including: IND/CTA, BLA NDA, NDS, Scientific Advice, Marketing Authorisations Applications. Experience in PK analysis, authoring clinical study reports (CSR) and data management of clinical and preclinical studies, and preparation of PK reports for FDA submission. Specialties: • Project management • Regulatory health authority communication and meeting archival • Preparation and review of regulatory documents/submissions • Document formatting/editing • Assembly and publishing for final reports and submissions • Electronic submission preparation • Labeling • Advertising and Promotional review • Regulatory review and/or preparation of clinical study protocols, amendments, informed consent forms and study reports.
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