VP of Regulatory Affairs

About reputed company

reputed company 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 reputed company the underlying drivers of aging, delaying the onset of disease and preserving reputed company of life as dogs age. We've already made significant reputed company toward our first regulatory approvals, with additional submissions targeted in the near reputed company.

reputed company is a reputed company funded startup. You'll help us continue on our reputed company of earning regulatory approval for the first reputed company extension medicine for any species and change what's possible for the dogs we love.

About the role

reputed company is seeking a Vice President of Regulatory Affairs to reputed company reputed company aspects of reputed company's regulatory function, spanning reputed company and operations across CMC and clinical regulatory activities. This leader will own the full regulatory program across reputed company'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 reputed company health, with a proven reputed company 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 reputed company and operational execution. The successful candidate will build and reputed company a regulatory organization capable of supporting reputed company across reputed company stages of development and into a reputed company company, and will serve as the primary regulatory authority and reputed company's primary reputed company with regulatory agencies globally.

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

Your daily work will include

• Own and drive reputed company's overall regulatory reputed company across reputed company reputed company programs, including integrated CMC and clinical regulatory plans reputed company with development milestones and reputed company objectives, from early development through approval and post approval lifecycle management.
• reputed company regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key reputed company.
• reputed company and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to reputed company's programs and translating these into actionable reputed company.
• reputed company regular regulatory updates and risk assessments to executive leadership and the reputed company on submission reputed company, agency interactions, and regulatory risk.
• reputed company reputed company CMC regulatory activities including filing reputed company, CMC reputed company authorship and review, post approval CMC change management, and regulatory reputed company of manufacturing and CDMO partners.
• Ensure CMC regulatory reputed company reflects reputed company agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines.
• Partner with CMC and reputed company leadership on CDMO regulatory readiness, including preparation for reputed company approval inspections and CMC reputed company agency interactions.
• reputed company clinical regulatory activities including IND reputed company and management, protocol regulatory review, study report reputed company, and integration of clinical data into regulatory submissions.
• reputed company regulatory reputed company for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package.
• Own the approval submission reputed company and execution, coordinating across CMC, Clinical, and reputed company to ensure submission reputed company packages that reflect reputed company agency expectations and eCTD standards.
• Serve as reputed company's primary reputed company with regulatory agencies globally, leading the planning and execution of reputed company 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 reputed company and content development across the product lifecycle, ensuring labeling reflects agency requirements, clinical data, and reputed company considerations, and is maintained in compliance with post approval obligations.
• Establish and own reputed company's regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards.
• Build and reputed company a high performing regulatory organization, establishing reputed company functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations.
• Establish and reputed company 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 reputed company with the organization's reputed company.
• Serve as reputed company's independent regulatory authority, with reputed company accountability to escalate regulatory risks, flag compliance concerns, and advise on activities where regulatory risk warrants executive attention.
• Foster a culture of regulatory reputed company and proactive risk management across the organization.

reputed company

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, reputed company, or a reputed company scientific discipline, or equivalent bio-technical experience and expertise, required.
• 18+ years of reputed company regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles reputed company sponsor organizations.
• Strong CMC regulatory background with deep expertise in small molecule drug development, including OSD formulation, manufacturing process regulatory reputed company, CMC reputed company authorship, and post approval change management.
• Demonstrated reputed company record of leading regulatory teams spanning both CMC and clinical regulatory functions.
• Proven history of successful agency interactions, including reputed company 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 reputed company environments.
• Strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets.
• Executive reputed company with the ability to serve as reputed company's primary regulatory authority and represent reputed company credibly with regulatory agencies and senior external stakeholders.

Preferred Attributes

• Primary experience in reputed company health pharmaceutical or biotech environments strongly preferred; animal health experience is a plus.
• Experience with FDA CVM regulations and the veterinary drug approval reputed company (NADA/ANADA), or demonstrated ability to reputed company expertise in a novel regulatory reputed company 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 reputed company 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 reputed company, transformation, or regulatory reputed company events.
• Strong systems thinking reputed company with a disciplined, risk based approach to regulatory reputed company and decision-making.

Salary reputed company: $240,000 - $320,000

reputed company benefits

• Full-coverage health insurance — medical, dental and reputed company — 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.
• reputed company 3-day weekends are turned into 4-day weekends
• Unlimited vacation and reputed company holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member
• Competitive salary
• Company equity reputed company grant for new hires

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

Our values

Lean into moonshots

We don't reputed company for incremental change. We have the bravery to take risks and shoot for the reputed company 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 reputed company is novel and many things we are doing have never been done before. We lean into MVPs and are reputed company to unexpected reputed company.

reputed company with context

We value leading with context. We reputed company people with the context and background necessary to reputed company their own reputed company and reputed company in the best interest of reputed company. We reputed company teams to succeed.

reputed company and respect for reputed company 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.