Job description

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval for the first in late 2025.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

We’re seeking a Regulatory Affairs Specialist to assist with regulatory submissions and operations.

Your work will support regulatory approval of programs and compliance with regulations around clinical trials.

This role is for someone who is in the early stages of their career in Regulatory Affairs. The ideal candidate should have the ability to work independently but happy to seek and receive guidance.

You will be reporting to our Senior Scientist, Regulatory Affairs.

Your daily work will include:

Assisting in the preparation and submission of regulatory filings including Serious Adverse Event (SAE) reporting and drug shipment notifications for our ongoing clinical trial.
Providing support with regulatory intelligence activities, including the research of new and existing FDA regulations or guidances.
Providing support to the regulatory team in responding to inquiries from regulatory agencies.

About you:

Have an advanced degree BS in a life sciences field, (MS, PhD) preferred
Good attention to detail, ability to write clear and concise documents
Interest in regulatory science and how to apply it to company programs
A broad understanding of drug development and approval processes
Have some experience in the biotech industry
RAPS certification is a bonus but is not required

Rate: $50/hr

Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.

Our values

Lean into moonshots

We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.

Opportunity is at the intersection

We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.

Expertise without ego

Titles do not determine who has a voice. We work on hard, technical problems and have a ton of fun while at it.

Learning by doing

Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.

Lead with context

We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.

Empathy and respect for all life

Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

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