Head of Regulatory CMC at loyalhealth

, , United States -

Full Time

Start Date

Immediate

Expiry Date

17 Dec, 25

Salary

250000.0

Posted On

18 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, CMC Documentation, FDA Submissions, Animal Health, Biotech Experience, Collaboration, Scientific Expertise, Risk Mitigation, Technical Writing, Formulation Decisions, Regulatory Compliance, Cross-Functional Leadership, Ethical Conduct, Problem Solving, Team Empowerment, Empathy

Industry

technology;Information and Internet

Description

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 within the next year. 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 You will be an integral leader of Loyal’s regulatory CMC function, with primary oversight of all CMC related documents and technical sections for submission to the FDA and other regulatory authorities. You will work closely with our CMC and quality teams (consisting of in-house technical experts and external consultants). Initial submissions will be through the FDA Center for Veterinary Medicine. This role is for someone who demonstrates strategic leadership, strong scientific expertise, and the ability to translate the drug development process and data into thorough and well supported regulatory submissions. The ideal candidate should be collaborative, low ego and creative. Your daily work will include Lead Loyal’s CMC regulatory strategy, and lead company to a complete CMC dossier for our three drug products, starting with LOY-002. Working closely with CMC team to ensure phase-appropriate data to support successful regulatory submissions, and benefits/drawbacks of certain formulation decisions. Preparing technical sections and other regulatory documents for submission, including the review of protocols and reports to ensure compliance with regulations. Contributing to regulatory plans, strategies, and risk mitigation across the portfolio. Offering regulatory advice to cross-functional teams, leading the drafting of submission responses to regulatory queries, and collaborating with CMC and Quality departments for Scale-up and Post-Approval Changes. Required Experience Bachelor’s degree in a scientific discipline; advanced degree and RAC are pluses but not required. 10+ years of experience in the pharmaceutical industry, with (1) 5+ years in animal health and (2) 5+ years in small, growing biotech companies. Well versed in animal health CMC regulatory requirements and pharmaceutical methods for active pharmaceutical ingredients, drug products and delivery devices. Extensive experience writing regulatory documents including Drug Master Files and/or CMC sections submitted as part of NADA. Demonstrated record of successful interactions with FDA’s CVM with respect to CMC submissions. Comfortable looking for ways to respectfully challenge regulatory precedent while maintaining scientific excellence, integrity, and ethical conduct. Salary Range: $180,000 - $250,000 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.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Lead Loyal’s CMC regulatory strategy and oversee the preparation of CMC dossiers for drug products. Collaborate with CMC and quality teams to ensure compliance and successful regulatory submissions.