Salini V

Associate Director, CReW, AstraZeneca, Ex-Alvotech l Eli Lilly l Novonordisk l TCS l Indegene l RCC

Role
Associate Director, Crew at AstraZeneca
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Salini V

I am a competent regulatory writer with over 14 years of core medical/regulatory writing experience and 8+ years of medical research experience. My expertise encompasses both regulatory writing (submission documents for FDA, EMA, PMDA, and other regional submissions) and scientific/publication writing. I have successfully led teams of writers, providing guidance, appraisals, and mentorship. My comprehensive project management skills span from proposal preparation to project completion, ensuring meticulous planning, timeline management, and risk mitigation. My experience also includes managing projects involving vendors and outsourced tasks, with a solid understanding of drug development and external regulations. I possess extensive therapeutic area knowledge in oncology, endocrinology, neuroscience, immunology, and cardiovascular diseases, along with a thorough understanding of biostatistics.

Experience

  1. Associate Director, Crew

    AstraZeneca

    Aug 2025 — Present · Bengaluru, IN

Education

  • University of Kerala

    Doctor of Philosophy - PhD, Biotechnology

  • University of Kerala

    Master of Science (MSc), Genetics

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Salini V — Associate Director, Crew at AstraZeneca in Bengaluru, KA, IN | Unifers