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 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 Director Regulatory Affairs, Clinical to serve as Loyal’s subject matter expert on FDA Center for Veterinary Medicine (CVM) regulatory strategy and clinical trial operations. This is a high-impact, hands-on role for someone who thrives on owning complex regulatory programs end-to-end — from INAD strategy through pivotal submission — and who brings deep expertise in FDA CVM clinical development. You will be the primary interface between Loyal and FDA CVM for clinical regulatory matters, owning our regulatory submissions, and helping shape the strategies that bring our longevity drugs to market. You will also manage 1–2 direct reports as the team grows.

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 10+ years of regulatory affairs experience. The ideal candidate should be a strategic thinker that is comfortable owning complex, first-of-kind regulatory programs with limited precedent, possess deep working knowledge of FDA CVM clinical development pathways and submission requirements and thrive in an environment operating with a great deal of autonomy in setting direction, making judgement calls, and driving programs and regulatory pathways forward in an agile organization.

You will be reporting to our VP of Regulatory Affairs .

Your daily work will include

• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence
• Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs
• Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports
• Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence
• Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline
• Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems
• Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support
• Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy
• Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs
• Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting 
• Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations
• Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

About you 

• Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree
• 10+ years of regulatory affairs experience in animal health with direct experience with owning FDA CVM relationships
• Hands on ownership experience with INADs, regulatory submissions, and FDA CVM in-person meetings
• Background across multiple drug types ideal (small molecules, biologics, injectables, etc.)
• You are data-driven and an analytical thinker; your regulatory experience is grounded in evidence and you communicate with excellence
• Strong and experienced writer that takes pride in clarity, accuracy and persuasive story telling about biological pathways or drug mechanisms and clinical impacts
• Extensive knowledge of FDA CVM regulatory pathways, policies, and limitations and where there are areas to innovate within those bounds
• Excellent judgement where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgement
• Collaborative with cross-functional teams and not afraid to be in the weeds while also being the subject matter expert
• Ability to operate as a high level individual contributor while also serving as a mentor to junior team members in order to upskill the department.
• Energized by a fast-paced startup environment 

Salary Range: $155,000 - $205,000

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

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 of 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 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.
• Provide regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions.
• 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.
• Provide regular regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk.
• 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.
• Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines.
• Partner with CMC and Quality leadership on CDMO regulatory readiness, including preparation for pre approval inspections and CMC related agency interactions.
• Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, study report oversight, and integration of clinical data into regulatory submissions.
• Oversee regulatory strategy for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package.
• 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.
• 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.
• Manage post approval regulatory obligations including periodic reports, labeling updates, post approval study commitments, and CMC variation filings, ensuring ongoing compliance with approval conditions.
• 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.
• Establish and own Loyal's regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards.
• Build and lead a high performing regulatory organization, establishing clear functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations.
• 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.
• 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.
• Foster a culture of regulatory excellence and proactive risk management across the organization.

About you

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise, required.
• 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations.
• 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.
• Demonstrated track record of leading regulatory teams spanning both CMC and clinical regulatory functions.
• Proven history of successful agency interactions, including pre submission meetings, formal correspondence, and advisory interactions across the product development lifecycle.
• Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership.
• Required experience with post approval regulatory activities, including CMC change management, labeling updates, periodic safety and annual reports, and post approval study commitments.
• Experience building and scaling regulatory organizations in startup or high growth environments.
• Strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets.
• 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

• Primary experience in human health pharmaceutical or biotech environments strongly preferred; animal health experience is a plus.
• 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.
• Experience filing with and interacting with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents) is a significant plus.
• Experience supporting first commercial launches and establishing post approval regulatory infrastructure in a company scaling toward commercialization.
• Familiarity with eCTD submission standards and regulatory operations best practices for late stage development companies.
• Experience leading organizations through significant growth, transformation, or regulatory milestone events.
• Strong systems thinking mindset with a disciplined, risk based approach to regulatory strategy and decision-making.

Salary Range: $240,000 - $320,000

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.