---
title: 'Senior Associate Specialist, Regulatory Operations at Loyal'
canonical: 'https://feeny.ai/job/senior-associate-specialist-regulatory-operations-loyal-united-states-bd9kwj4pttpt'
type: 'job'
last_seen: '2026-09-10'
---

# Senior Associate Specialist, Regulatory Operations at Loyal

- **Company:** Loyal
- **Location:** United States
- **Work type:** remote
- **Posted:** 2026-08-05
- **Last confirmed live:** 2026-09-10
- **Apply:** https://job-boards.greenhouse.io/loyal36/jobs/5381025008

## Job description

## About Loyal

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.

We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress toward our first regulatory approvals, with additional submissions targeted in the near future.

Loyal is a [well-funded startup](https://loyal.com/posts/125m-to-extend-dog-lifespan) with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.

## About the role

We’re seeking an experienced Sr. Associate Specialist, Regulatory Operations to  join the Regulatory Affairs team at Loyal who will be working directly on our day-to-day regulatory operations that support our programs. This is a role for someone who is familiar with the operational aspects of regulatory affairs, such as compiling and formatting regulatory submissions, electronically submitting materials to the FDA/CVM and is able to be accountable for creating, own and updating trackers regarding our submissions. Your work will directly shape the regulatory path to bring novel longevity therapeutics through FDA CVM approval for the first time in any species, setting regulatory precedent for an entirely new category of medications.

This role is for someone who has at least 3 years of regulatory ops experience. The ideal candidate should be in Regulatory Ops eager to contribute to regulatory filings for Loyal’s longevity pipeline. This person should be comfortable collaborating with others within Regulatory, as well as regularly interfacing with members of other teams, such as Research, Clinical Development and CMC. You should be comfortable with various regulatory submission types for therapeutics (IND/INAD, NDA/NADA, Biologics, Meeting Requests, Supplements, etc.) and be able to autonomously execute on tasks once the strategy has been outlined by Regulatory Ops leaders.

You will be reporting to our Head of Regulatory, CMC.

## Your daily work will include

- Assist in preparing and reviewing both Clinical and CMC regulatory submissions and reports
- Create and package submissions in the CVM eSubmitter tool, working from author drafted Word sections and returning eSubmitter output for author review
- Assemble, format, and publish submissions to FDA CVM and ex-US agencies, including INAD/JINAD correspondence, technical sections, amendments, annual reports, and meeting requests
- Manage transmission through the FDA Electronic Submissions Gateway, including account administration, receipt reconciliation, and troubleshooting failed transmissions
- Maintain the submission archive and correspondence log so that any prior commitment, agency comment, or filed document can be located quickly during a review cycle or an inspection
- Own regulatory document templates and the submission style guide
- Create and maintain submission trackers, and keep the regulatory activity source of truth current
- Collaborate with internal teams on product labeling and documentation
- Stay current on changes to FDA CVM and, if applicable, ex US authorities

## About you

- Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree
- 3-5 years of regulatory ops experience in human or animal health; animal health preferred
- Knowledge of various regulatory submission types (H-submissions, Z-submissions, etc)
- Hands on experience with drafting, packaging and submitting regulatory submission and communications to the FDA via the ESG electronic submission system
- Familiarity with ex-US submission is not required but preferred
- Collaborative with cross-functional teams who contribute to the various submissions (Research, Clinical, CMC)
- Ability to operate with a degree of autonomy and accountability when managing submissions
- RAPS certification is a bonus but is not required
- Excited about working at the forefront of regulatory category creation

Salary range: $110,000 - $160,000

Loyal benefits

- Full-coverage health insurance — medical, dental and vision — for you and your dependents
- $1,000 home office equipment stipend
- $1,200/year learning budget for books, courses, etc.
- $250/month wellness budget for gym, cleaners, spa, food, etc.
- All 3-day weekends are turned into 4-day weekends 🎉
- Unlimited vacation and paid holidays
- Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
- Competitive salary
- Company equity options grant for new hires

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.

## About Loyal

## Company Overview
- **One-liner**: Loyal is a clinical-stage veterinary medicine company developing the first FDA-approved drugs intended to extend the lifespan and healthspan of dogs.
- **Entity Type**: Private (Series C)
- **Headquarters**: San Francisco, California, United States
- **Founded**: 2020
- **Founders**: Celine Halioua

## Core Business
- **Primary industry**: Veterinary Medicine / Animal Health Biotechnology
- **Target customers**: B2B (veterinary clinics) and B2C (dog owners)
- **Mission**: To help dogs live longer, healthier lives by developing drugs that target the underlying processes of aging.

## Products & Services
For each major offering:
- **[LOY-002](https://loyal.com)**: A once-daily pill targeting age-associated metabolic dysfunction in senior dogs (ages 10+, 14+ lb). It is the lead drug program and has completed the second of three major requirements for FDA conditional approval. Designed to extend lifespan and maintain quality of life.
- **[LOY-001](https://loyal.com)**: A drug program targeting age-associated metabolic dysfunction (currently in earlier stages of development).
- **Loyal Learning Hub**: A free library of RACE-approved continuing education courses for veterinary teams to improve care for senior dogs.

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Total Funding**: $238.0M across six rounds
  - Series C (2026-02-01): $100M [LinkedIn](https://www.linkedin.com/company/loyalfordogs)
  - Series B (2025-02-01): $22M
  - Series B (2024-03-01): $45M
  - Series A (2022-04-01): $13M
  - Series A (2021-09-01): $27M
- **Key Metric**: Annual Revenue of $2.0M (pre-commercial stage) [LinkedIn](https://www.linkedin.com/company/loyalfordogs)
- **Notable Investors/Partners**: 2 investors in Series B (2025), 3 investors in Series C (2026) [LinkedIn](https://www.linkedin.com/company/loyalfordogs)
- **Growth Signals**: Headcount grew 53.3% year-over-year to 71 employees [LinkedIn](https://www.linkedin.com/company/loyalfordogs). Targeting commercial launch of LOY-002 in 2027. Completed 2/3 major FDA review sections for LOY-002 as of early 2026 [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008).

## Competitive Advantages
- **First-to-market**: Pioneering the first FDA-approved lifespan extension drug for any species, creating a new category in veterinary prescription medicine.
- **Regulatory moat**: Achieving FDA conditional approval for a longevity drug is an extremely difficult technical and regulatory pursuit, creating a significant barrier to entry.
- **Targeting aging itself**: Unlike most veterinary drugs that treat specific diseases, Loyal targets the underlying drivers of aging to delay the onset of multiple age-related conditions.
- **Strong clinical trial infrastructure**: 70 veterinary clinics enrolled in the STAY clinical trial, with over 1,317 dogs accepted [loyal.com](https://loyal.com).

## Strategic Focus
- **Regulatory approval**: Completing the third and final FDA review section for LOY-002 and targeting submission in late 2026 [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008).
- **Commercial launch preparation**: Scaling the company from ~70 to ~150 people, building a customer service organization, and leading product distribution platform buildout for prescription drug distribution, targeting a 2027 launch [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008).
- **AI-leveraged efficiency**: Deploying AI tooling across operations, finance, recruiting, and customer service to scale leverage with the team [Greenhouse](https://job-boards.greenhouse.io/loyal36/jobs/5235415008).
- **Pipeline expansion**: Developing a portfolio of three drug programs (LOY-002, LOY-001, and others) targeting different aspects of aging.

## Why Work Here
- **Mission-driven**: The company is deeply committed to helping dogs live longer, healthier lives — a compelling purpose for many job seekers.
- **Culture**: Values include "Empathy and respect for all life," "Expertise without ego," "High agency, high humility," and "Lead with transparency and context" [loyal.com/careers](https://loyal.com/careers).
- **Remote-first**: All open roles are listed as "Remote - US" [Greenhouse](https://job-boards.greenhouse.io/loyal36).
- **Generous benefits** [loyal.com/careers](https://loyal.com/careers):
  - Full-coverage health insurance (medical, dental, vision) for you and dependents
  - $1,000 home office equipment stipend
  - $1,200/year learning budget
  - $250/month wellness budget (gym, cleaners, spa, food)
  - All 3-day weekends turned into 4-day weekends
  - Unlimited vacation and paid holidays
  - "Paw-ternity leave" — adopt a dog and get a day off
  - Annual company retreat at beautiful locations (recently: Tahoe, Cape Cod)
  - Competitive salary and equity options grant
- **Leadership**: Founded and led by a first-gen female CEO, Celine Halioua. The company is an equal opportunity employer.
- **Growth opportunity**: As a well-funded startup targeting a 2027 commercial launch, there is significant potential for career growth and impact.

## Sources
1. [loyal.com](https://loyal.com)
2. [loyal.com/careers](https://loyal.com/careers)
3. [LinkedIn - Loyal](https://www.linkedin.com/company/loyalfordogs)
4. [Greenhouse - Loyal Jobs](https://job-boards.greenhouse.io/loyal36)
5. [Greenhouse - COO Job Posting](https://job-boards.greenhouse.io/loyal36/jobs/5235415008)

## Other roles at Loyal

- [Senior Statistician, Research & Development](https://feeny.ai/job/senior-statistician-research-development-loyal-united-states-0r3knng5j7zr) — United States
- [Director, FP&A](https://feeny.ai/job/director-fp-a-loyal-united-states-nb572c2e9bfg) — United States
- [Principal Analytical QA Specialist, Drug Substance](https://feeny.ai/job/principal-analytical-qa-specialist-drug-substance-loyal-united-states-hva9wqft24jn) — United States
- [Senior Principal Scientist, Drug Substance](https://feeny.ai/job/senior-principal-scientist-drug-substance-loyal-united-states-6fv71bjzb5w0) — United States
- [Director, Regulatory Affairs - Clinical](https://feeny.ai/job/director-regulatory-affairs-clinical-loyal-united-states-1j9et5dxrqdn) — United States