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Swapna Teja Gundala

Parexel

Manager, Regulatory Affairs

Global Regulatory Affairs Leader with 17+ years of experience across biologics, vaccines, biosimilars, and cell & gene therapies in US, EU, and ROW markets. Proven expertise in global regulatory strategy, CMC, marketing authorizations, and lifecycle management, with a strong track record of successful approvals and effective health authority engagement. Recognized for driving programs from early development through commercialization, leveraging strategic FDA/EMA interactions to accelerate approvals and mitigate risk. Forward-looking leader integrating AI and digital solutions into regulatory processes, utilizing automation, intelligent dossier management, and data-driven insights to enhance efficiency, quality, and speed.

1 talk

Speaking

Titles as listed at each event

2026