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Senior Associate Specialist, Regulatory Operations Loyal · Remote - US $110k–160k 35 days ago Remote Biotech/Pharma

Principal Analytical QA Specialist, Drug Substance Loyal · Remote - US $150k–190k 56 days ago Remote Biotech/Pharma

Senior Director, Quality Control & Analytical Development Loyal · Remote - US $230k–280k 62 days ago Remote Biotech/Pharma

Senior Director, Clinical Development Loyal · Remote - US $230k–270k 125 days ago Remote Biotech/Pharma

Director, Regulatory Affairs - Clinical Loyal · Remote - US $155k–205k 140 days ago Remote Biotech/Pharma

Biotech/Pharma

56 days ago

Principal Analytical QA Specialist, Drug Substance

Loyal · Remote - US

Pay

$150k–190k

Setting

Remote

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Back to jobs Principal Analytical QA Specialist, Drug Substance Remote - US Apply 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 in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. 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 Principal Analytical QA Specialist, Drug Substance to provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management activities supporting the development and commercialization of Loyal's veterinary pharmaceutical products. Operating within Loyal's fully outsourced manufacturing network, the position supports batch disposition of active pharmaceutical ingredient (API) / drug substance, drug product, packaging and labeling through review and approval of protocols, reports, analytical methods, and associated GMP documentation. The role works collaboratively with Technical Operations and Analytical Development / Quality Control to ensure that the manufacture and laboratory analysis of drug substance, drug product, packaging & labeling of finished drug product conforms with cGMPs, VICH and global regulatory requirements. This position also partners with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. Your daily work will include Manufacturing & Analytical Quality Oversight Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase. Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development. Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.). Batch Release / Disposition & Quality Systems Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions. Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches are compliant with cGMP requirements. Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process. Regulatory & Cross-Functional Support Perform data integrity and compliance assessments including review against source documentation for regulatory submissions. Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines. Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly About you B.S./M.S. degree in in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field) Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles. Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems. Experience managing CDMOs and collaborating effectively across cross-functional teams. Capable of working successfully in a team/matrix environment and independently, as required. Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously. Ability to convey both written and verbal information effectively and efficiently. Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail. Willingness to travel (10%). Core Competencies: Strong technical judgment and problem-solving Attention to detail and commitment to quality Excellent written and verbal communication Ability to influence cross-functional teams and external partners Effective project and time management Collaborative mindset with a continuous improvement focus Preferred Qualifications: Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus. Experience auditing suppliers, CDMOs, and CTLs. Experience with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems. Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products preferred. Experience with international regulatory environments (EU, Canada, etc.) a plus Salary Range: $150,000 - $190,000 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 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. Create a Job Alert Interested in building your career at Loyal? Get future opportunities sent straight to your email. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Do you now or in the future require sponsorship for employment?* Select... LinkedIn Profile Website Submit application Powered by

Listed by Loyal for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

140 days ago

Director, Regulatory Affairs - Clinical

Loyal · Remote - US

Pay

$155k–205k

Setting

Remote

Apply Sign in to favorite Permalink

Back to jobs Director, Regulatory Affairs - Clinical Remote - US Apply 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 with with 3+ years in animal health, 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 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. Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Do you now or in the future require sponsorship for employment?* Select... LinkedIn Profile Website Submit application Powered by

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