Regulatory Manager

Loyal is developing drugs to extend dog lifespan; we aim to build the defining aging company. Loyal was founded in early 2020 and has raised over $50M from Khosla, First Round Capital, Collaborative Fund, Longevity Fund, Quiet Capital, BoxGroup, and more.

Loyal is working on bringing to market the first drugs intended to extend dog lifespan (years of life) and healthspan (quality of life). We aspire to build a pharma brand people love around deeply technical products.

While we are currently focusing on dog drugs, our ultimate aim is to take what we learn in dogs to leapfrog into human aging drugs, and build the company that catalyzes and captures the public’s excitement around aging therapeutics.

We are seeking a Regulatory Manager to assist with preparation of our regulatory strategy and documentation. This position will be critical in moving our products towards approval for dogs and in bridging to humans. It is a great position for someone interested in the regulatory area but with no previous experience.

Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants.

As part of the Regulatory and Strategy Team you will:

• • Prepare documents for submission, working with teams across the company
  • Review and summarize scientific literature for inclusion in submissions
  • Provide detailed review of documents to ensure high quality and internal consistency
  • Become familiar with FDA guidance documents and incorporate them into our strategies
  • Contribute to the regulatory strategy for dog and human products
  • Attend aging conferences and glean information on approaches to regulatory approval strategies

Proficiencies:

• • Scientific and technical writing skills
  • Ability to communicate in an engaging manner verbally and in writing
  • Close attention to detail and skill in producing high quality written work
  • Proven ability to drive tasks and projects to completion and stick to timelines
  • Ability to think strategically and explain how tasks fit into the big picture
  • Ability to deal with ambiguity and work in novel areas
  • Willing to read and learn about new areas of science
  • Science based B.S., M.S. or PhD
  • Knowledge of regulatory science is a bonus but not required

How you work and think:

• • Mission driven - able to prioritize and put day to day work in the context of the overall company goals
  • Able to find satisfaction in a job well done
  • Excited by challenges and the opportunity to build something novel
  • Able to work in a fast paced and ever-changing environment
  • Detail oriented, disciplined, naturally seek ownership and responsibility, and happy working on a mix of the fascinating and the mundane
  • Concise, logical thinker who can communicate complicated topics with ease
  • Growth mindset, value transparency, seek out feedback and iteration cycles
  • Empathy to others and low ego

Why you may not like this role:

• • We are still relatively new, therefore many systems are either not in place or being iterated on. Tolerance for ambiguity and a bit of chaos is key
  • The strategy can change rapidly based on the science
  • As with other companies we are still figuring out hybrid remote working and communication

Logistics:

• • Full-time position. May be remote or based in San Francisco, CA - our offices are on Market Street near Noe Valley Management of key activities conducted with external research organizations and partners
  • Competitive salary depending on your background & company shares
  • Full coverage health/dental/vision
  • Monthly learning budget for books and self-improvement
  • Start ASAP

Health | Good health is critical to every other human (and animal!) experience. We believe health is a fundamental right and are dedicating our lives to maximizing health and developing better medicines for the worst diseases.

Seeking & Feedback Loops | Uniquely in biology, there is a predetermined truth of whether a specific drug will work or not — we just have to catch up with biology! We seek out this truth and do not shy away from inconvenient truths. This holds for personal development too: we are always searching for feedback loops and embody a perpetual growth mindset.

Transparency | We believe full transparency in thoughts, opinions, intentions, and actions (both good ones and mistakes) is a better way to build a business and work together.

Morality & Empathy | We are developing medicines that may one day be given to a living animal, medicines that if designed badly could hurt that animal instead of help. This is a huge responsibility and should be respected as such. Our work needs to adhere to the strictest moral code and always integrate empathy for the patient.

Kindness | Great business(wo)men do not need to be ruthless — you can execute excellently with kindness.

Dog gifs | We love them.