Chief Regulatory Officer (FDA, EMA, MHRA)
- Regulatory
- Full-time
- Hyderabad, IN
- Remote friendly
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 Million Lives Mission. To that end, we are developing first-in-class vaccines against Hepatitis C Virus, Strep A, and adult pulmonary TB, broadly-protective best-in-class vaccines against COVID-19, influenza, and HPV, and precision immunotherapies against hard-to-treat solid tumours such as liver cancer and pancreatic cancer.
Our work is funded by Vitalik Buterin’s Balvi Fund, the Gates Foundation, the US Biomedical Advanced Research and Development Authority (BARDA), and Renaissance Philanthropy. Our first vaccine program will begin a Phase I clinical trial in the US in mid-2026 conducted & sponsored by the National Institutes of Health (NIH). We intend to put 6 novel vaccines and immunotherapies into Phase I clinical trials over the next 3 years.
No matter the job title, each person’s role at PopVax is ultimately focused on helping take safe & effective new medicines that represent a step-change improvement on the current standard-of-care to the people who need them as fast as possible. If you want to work where the ambition is high, the learning curve is steep, and the work matters to billions, you’ll feel at home here.
If you’re excited by the idea of advancing scientific, clinical, and regulatory frontiers of vaccines and immunotherapies, spending each day developing medicines with the potential to save millions of lives, and building a generational global pharmaceutical company in India along the way – join us!
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 independently in a fast-paced environment without the benefit of a supporting regulatory team or junior regulatory executives for the immediate future. Previous experience doing regulatory work for a successfully-authorised 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.