Senior Regulatory Manager, Quality

About Fullscript Founded in 2014, Fullscript is a healthcare platform built on the belief that care should treat the whole person. Today, more than 125,000 practitioners and 10 million patients rely on us for high‑quality supplements, industry‑leading labs, and tools that help them follow through on care. Our purpose is simple: to help people get better. Every system we design and every program we deliver supports practitioners in providing care that is more personal, more efficient, and more effective. Let’s build a healthier future together and make healthcare whole. Senior Regulatory Manager The Senior Regulatory Manager plays a key role in leading regulatory strategy and ensuring compliance across our diverse product ecosystem—from supplements and cosmetics to diagnostic test kits and food products—and supports operations spanning FDA, FTC, Health Canada, CFIA, CLIA, and other relevant frameworks. Key Responsibilities Lead and mentor the Regulatory team, fostering a culture of ownership, accountability, and professional growth. Oversee regulatory operations and readiness for audits and inspections across authorities such as FDA, FTC, Health Canada, CFIA, CLIA. Manage and maintain regulatory registrations, facility licensing, and supplier qualifications. Collaborate with internal teams to confirm product labeling and marketing claims across supplements, cosmetics, foods, and diagnostics. Partner on complaint handling, recalls, and corrective actions in conjunction with Distribution, Finance, Customer Experience, and Brand teams. Work cross‑functionally with Legal, Quality, and Distribution to proactively anticipate regulatory changes and strengthen processes for SOPs and documentation. Provide regulatory oversight for diagnostic laboratories and self‑collection testing kits, ensuring compliance with CLIA and related regulations. Monitor and report on key regulatory KPIs, providing performance insights and recommendations to leadership. Required Qualifications 10+ years of regulatory compliance experience, including 5+ years in a management role overseeing regulatory professionals. Deep working knowledge of U.S. and Canadian regulations for dietary supplements, foods, cosmetics, diagnostics, OTCs, and medical devices. Strong familiarity with FDA, Health Canada, CFIA, CLIA, FTC, and Prop 65 regulations. Experience with cGMP and NSF (or equivalent) requirements. Proven ability to lead regulatory strategy, manage audits, and make informed decisions in high‑stakes situations. Bachelor’s degree in a life‑sciences field (e.g., Food Science, Biology, Biochemistry, Clinical Laboratory Science); advanced degree preferred. Exceptional leadership and communication skills, with the ability to manage and influence cross‑functional stakeholders effectively. Preferred Qualifications Ability to translate complex regulatory requirements into clear guidance for non‑technical stakeholders. Experience implementing or optimizing regulatory software systems or digital quality management tools. Comfort navigating ambiguity in evolving regulatory environments. Background in supplier or contract‑manufacturer auditing, with a focus on continuous improvement and partnership development. Benefits and Perks Competitive compensation package including equity. 401(k) matching (US) / RRSP matching (CAD). Flexible PTO policy. Employee discount on Fullscript catalog for family and friends. Ability to work wherever you work well. Culture and Values We value innovation—we push boundaries and always look for better ways. We support growth through learning, mentorship, and meaningful work. We care about balance with flexible work options and time off when you need it. Additional Information Seniority level: Director Employment type: Contract Legal & Diversity Statements Fullscript is an equal‑opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request—email (email protected) for support. Before joining the team, all candidates who receive and accept an offer will complete a background check. We use AI tools to support parts of our hiring process, like screening and reviewing responses. Final decisions are always made by people. This process complies with privacy and employment laws across Canada and the U.S. Contact & Application Please submit all applications directly through our careers page. Due to the high volume of interest, we are not able to respond to individual emails or messages about this posting. If your background aligns with what we’re looking for, a member of our team will reach out to you directly. #J-18808-Ljbffr