Lalitha Goteti
Associate Director @Pfizer
Signup · Get unlimited contacts
WORK HISTORY
Associate Director @Pfizer
Products: Paxlovid, Danuglipron, Rimegepant (Nurtec)Roles: Submission Lead (US and EU [sNDA and Type II variation])Document types: CSRs, Summary Documents (Modules 2.7.3 and 2.7.4), Clinical Overview, Briefing Documents Supports/Manages/Co-ordinates: Diversity action plans (DAPs), Virology sequencing/infectivity reports
EDUCATION
Bangalore University
Master's degree, Biochemistry
ABOUT LALITHA GOTETI
I’m a Regulatory content architect (ie,Medical Writer) with a passion for transforming complex clinical and safety data into clear, accurate, and impactful documents that supports regulatory success and scientific communication. With experience spanning multiple therapeutic areas including oncology, anti-infectives, immunology etc, I bring a blend of scientific rigour, strategic thinking, and collaborative spirit to every project.Whether I’m drafting CSRs, aggregate periodic safety reports, contributing to submission dossiers, or aligning with global regulatory standards, I focus on clarity, compliance, and connection. I thrive in cross-functional teams, ask thoughtful questions, and aim to make every document not just complete—but compelling.If you’re looking for someone who can bridge science and storytelling across diverse therapeutic landscapes, I’d love to connect.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.