Chief Regulatory Officer (FDA, EMA, MHRA) PopVax

0.0 years

0 Lacs

hyderabad, telangana, india

Remote

PopVax is an Indian full-stack biotech building first-in-class and best-in-class vaccines and cancer immunotherapies using machine learning-driven design and relentless empiricism. We design, develop, and manufacture our own RNA medicines end-to-end because we believe great pharmaceutical science can only flourish in tight feedback loops that iterate rapidly. PopVax's experimental work and clinical dose production is based at the RNA Foundry, our integrated R&D and GMP-capable clinical dose production facility in Hyderabad. PopVax's north star is our goal of developing novel vaccines and therapeutics over the next decade with the cumulative ability to save 1 million lives each year the Milli...

Posted 5 days ago

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Chief Regulatory Officer PopVax

8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

As a senior regulatory executive at PopVax, your role will involve overseeing the end-to-end qualification of novel vaccines and biologics in the US through FDA processes. This includes managing the entire process from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Your expertise in navigating the regulatory landscape will be crucial in ensuring successful approval and market entry for our innovative medicines. Key Responsibilities: - Lead the regulatory strategy and submission process for novel vaccines and biologics in the US, ensuring compliance with FDA requirements at every stage of development. - Collaborate with cross-functional t...

Posted 3 weeks ago

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Chief Regulatory Officer PopVax

8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2,...

Posted 3 months ago

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