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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Regulatory Affairs- EU Market | Pre & Post Approval | Hyderabad | WFO V3 Staffing

2.0 - 7.0 years

4 - 6 Lacs

hyderabad

Work from Office

Greetings of the day ! Our reputed MNC Client is hiring for: Designation: Regulatory Affairs- EU Market- Pre & Post Approval Location: Hyderabad Shift: General Work Mode: WFO (5 days working) Interview Mode: F2F interview NOTE: Looking for candidates from Generic Pharma and not from API as this is for formulation Role & responsibilities: 1. Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module 2. Well versed with EU- Regulatory guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines) 3. Clear Knowledge of basic aspect...

Posted 2 months 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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