Chief Regulatory Officer (FDA, EMA, MHRA)
- Remote friendly
2022-09-19 19:22:59 UTC
PopVax is an Indian biotechnology company based in Hyderabad building a novel thermostable, low-cost, and safe second-generation mRNA platform for rationally-designed broadly-protective multi-epitope vaccines. We’re starting with a 4-8 °C refrigerator-stable booster vaccine candidate that is intended to protect against the entire sarbecovirus sub-family, including current and future strains of SARS-CoV-2 (the virus which causes COVID-19), and some other beta-coronaviruses such as MERS-CoV. We intend to begin clinical trials for this candidate in the US early next year.
We're looking for a senior regulatory executive with deep expertise in the end-to-end qualification of novel vaccines and biologics in the US through FDA processes, from preclinical development to animal trials to GMP manufacturing to human trials (IND), all the way through to licensure (BLA).
The ideal candidate will also have qualified vaccines or other biologics in other stringent regulatory regimes such as the European Union (EMA), Canada (Health Canada), the UK (MHRA), and Japan (PMDA). They will be comfortable working indepedently in a fast-paced enviroment without the benefit of a supporting regulatory team or junior regulatory executives for the immediate future. Previous experience doing regulatory work for a succesfully-authorized COVID-19 vaccine in any of these countries is a major plus.
For the right candidate, we are open to this role being remote and performed from any country in the world (save those sanctioned by the US in ways that would be detrimental to the performance of the role).
We offer very competitive compensation, comprehensive health insurance covering immediate family (including pre-existing conditions), and, most importantly, a collaborative work environment focused on solving the cutting-edge multidisciplinary challenges of our novel mRNA platform.