Vice President, Regulatory Affairs

# 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. You’ll help us continue on our path of earning regulatory approval for the first lifespan extension medicine for any species and change what’s possible for the dogs we love.

# About the role
Loyal is seeking a Vice President, Regulatory Affairs to lead all aspects of the company’s regulatory function, spanning strategy and operations across CMC and clinical regulatory activities. This leader will own the full regulatory program across Loyal’s pipeline, from early development through approval and into post‑approval lifecycle management.

A strong CMC regulatory background is essential. The ideal candidate brings deep expertise in small molecule drug development, ideally from human health, with a proven track record leading integrated regulatory teams, executing successful agency interactions, and bringing products to approval. Demonstrated experience in post‑approval regulatory activities is required.

This role requires both strategic vision and operational execution. The successful candidate will build and lead a regulatory organization capable of supporting Loyal across all stages of development and into a commercial company, and will serve as the primary regulatory authority and the company’s primary interface with regulatory agencies globally.

The role reports to senior executive leadership and partners closely with leadership across TechOps, Quality, Clinical, Operations, and Commercial.

# Your daily work will include
– **Own regulatory strategy** — Own and drive Loyal’s overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans aligned with development milestones and commercial objectives, from early development through approval and post‑approval lifecycle management.
– **Regulatory input** — Provide regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions.
– **Regulatory intelligence** — Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to Loyal’s programs and translating these into actionable strategy.
– **Regulatory updates** — Provide regular regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk.
– **CMC regulatory leadership** — Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, post‑approval CMC change management, and regulatory oversight of manufacturing and CDMO partners.
– **CMC expectations** — Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines.
– **CDMO readiness** — Partner with CMC and Quality leadership on CDMO regulatory readiness, including preparation for pre‑approval inspections and CMC‑related agency interactions.
– **Clinical regulatory leadership** — Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, study report oversight, and integration of clinical data into regulatory submissions.
– **Pivotal study strategy** — Oversee regulatory strategy for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package.
– **Submission strategy** — Own the approval submission strategy and execution, coordinating across CMC, Clinical, and Quality to ensure submission‑ready packages that reflect current agency expectations and eCTD standards.
– **Agency liaison** — Serve as the company’s primary liaison with regulatory agencies globally, leading the planning and execution of pre‑submission meetings, formal submissions, and ongoing agency communications.
– **Post‑approval management** — Manage post‑approval regulatory obligations including periodic reports, labeling updates, post‑approval study commitments, and CMC variation filings, ensuring ongoing compliance with approval conditions.
– **Labeling strategy** — Own labeling strategy and content development across the product lifecycle, ensuring labeling reflects agency requirements, clinical data, and commercial considerations, and is maintained in compliance with post‑approval obligations.
– **Regulatory systems** — Establish and own Loyal’s regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards.
– **Team leadership** — Build and lead a high‑performing regulatory organization, establishing clear functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations.
– **Governance frameworks** — Establish and scale regulatory governance frameworks and regulatory procedural documents — including submission templates, agency meeting management procedures, labeling review workflows, and regulatory decision documentation standards — that meet eCTD and global filing requirements and scale with the organization’s growth.
– **Regulatory authority** — Serve as the company’s independent regulatory authority, with clear accountability to escalate regulatory risks, flag compliance concerns, and advise on activities where regulatory risk warrants executive attention.
– **Regulatory culture** — Foster a culture of regulatory excellence and proactive risk management across the organization.

# About you
– **PhD requirement** — Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio‑technical experience and expertise, required.
– **Experience requirement** — 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations.
– **CMC expertise** — Strong CMC regulatory background with deep expertise in small molecule drug development, including OSD formulation, manufacturing process regulatory strategy, CMC section authorship, and post‑approval change management.
– **Team leadership** — Demonstrated track record of leading regulatory teams spanning both CMC and clinical regulatory functions.
– **Agency interactions** — Proven history of successful agency interactions, including pre‑submission meetings, formal correspondence, and advisory interactions across the product development lifecycle.
– **Approval experience** — Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership.
– **Post‑approval experience** — Required experience with post‑approval regulatory activities, including CMC change management, labeling updates, periodic safety and annual reports, and post‑approval study commitments.
– **Startup experience** — Experience building and scaling regulatory organizations in startup or high‑growth environments.
– **ICH knowledge** — Strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets.
– **Executive presence** — Executive presence with the ability to serve as the company’s primary regulatory authority and represent Loyal credibly with regulatory agencies and senior external stakeholders.

# Preferred Attributes
– **Human health experience** — Primary experience in human health pharmaceutical or biotech environments strongly preferred; animal health experience is a plus.
– **CVM experience** — Experience with FDA CVM regulations and the veterinary drug approval pathway (NADA/ANADA), or demonstrated ability to develop expertise in a novel regulatory framework quickly.
– **Global filings** — Experience filing with and interacting with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents) is a significant plus.
– **Commercial launch** — Experience supporting first commercial launches and establishing post‑approval regulatory infrastructure in a company scaling toward commercialization.
– **eCTD familiarity** — Familiarity with eCTD submission standards and regulatory operations best practices for late‑stage development companies.
– **Growth leadership** — Experience leading organizations through significant growth, transformation, or regulatory milestone events.
– **Systems thinking** — Strong systems thinking mindset with a disciplined, risk‑based approach to regulatory strategy and decision‑making.

# Salary Range
$240,000 – $320,000

# Loyal benefits
– **Health insurance** — Full‑coverage health insurance — medical, dental and vision — for you and your dependents
– **Home office stipend** — $1,000 home office equipment stipend
– **Learning budget** — $1,200/year learning budget for books, courses, etc.
– **Wellness budget** — $250/month wellness budget for gym, cleaners, spa, food, etc.
– **4‑day weekends** — All 3‑day weekends are turned into 4‑day weekends
– **Vacation** — Unlimited vacation and paid holidays
– **Paw‑ternity leave** — Adopt a dog and get a day off with your new family member
– **Competitive salary** — Competitive salary
– **Equity** — 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
## Moonshots, derisked methodically
Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de‑risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure.

## Opportunity is at the intersection
We lean into combining disciplines, expertise, 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 push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat.

## High agency, high humility
Most of what we’re doing has never been done before, so we can’t rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don’t know what we don’t know, and design small experiments where we can fail safely, without jeopardizing the bigger mission.

## Lead with transparency and context
We proactively and consistently share the why behind our strategy — not just the what — because we believe sharing context enables great people to make great decisions.

## Empathy and respect for all life
Our patients are not just numbers. We deeply respect the value of every life, large and small, and take our ethical responsibility to the families we treat extremely seriously.

Learn more here