Dipika Tuteja S
Regulatory Strategy | PhD, PPM, RAC-US
- Role
- Senior Manager, Regulatory Strategy at Bristol Myers Squibb
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Dipika Tuteja S
Bristol Myers Squibb relies on the expertise of a certified regulatory affairs (RA) professional with over five years of experience in clinical and CMC regulatory strategy. Their work spans key therapeutic areas, including cardiovascular, oncology, and rare diseases. With a strong focus on global submissions such as INDs, NDAs, and MAAs, they contribute to aligning regulatory pathways for innovative small molecules and biologics. Known for their technical acumen in molecular biology and assay development, they support cross-functional teams to navigate complex health authority communications across US, EU, and Canadian markets. Their strategic insight, coupled with a commitment to advancing regulatory processes, ensures seamless product development and market approvals.
Experience
Senior Manager, Regulatory Strategy
Nov 2021 — Present · Brisbane, CA, US
Education
Keck Graduate Institute
PPM, Post-doctoral Professional Masters, Bioscience Management
University of California, Davis
Post-doctoral fellowship, Molecular Cardiology
Delhi University
PhD, Molecular Biology
Skills
- Grant Writing
- Biotechnology-Based Therapeutics
- Business Strategy
- In Vitro
- Cell
- Scientific Writing
- Orphan Drugs
- Cell Culture
- Tissue Culture
- In Situ Hybridization
- Protein Expression
- Market Analysis
- Entrepreneurial Business Law
- Apoptotic Assays
- Biotechnology
- Protein Purification
- Stem Cells
- Genomics
- Transfection
- Molecular Cloning
- Cell Biology
- Financial Acumen
- Biochemistry
- Ion Channels
- Theoretical Electrophysiology
- Pcr
- Dna
- Assay Development
- Molecular Biology
- Fluorescence Microscopy
- Confocal Microscopy
- Molecular Microbiology
- Project Management
- Sirna
- Microarray
- Rt-Pcr
- Qrt-Pcr
- Business Acumen
- Comparative Genomics
- Qpcr
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