Senior Regulatory Manager, Quality
USA Remote / Boston, MA / Manchester, NH / Florida / Chicago, IL / Canada Remote / Ottawa, ON / Toronto, ON
Legal & Quality – Quality /
Full Time /
Remote
About Fullscript
Founded in 2011, Fullscript started by solving one problem: helping practitioners access and prescribe the products they trust to deliver integrative care.
What began as a simple solution has evolved into a health intelligence platform that powers every part of care.
Today, 125,000 practitioners rely on Fullscript for clinical insights, lab interpretations, patient analytics, education, and access to high-quality supplements. They support over 10 million patients who use Fullscript to stay connected to their care plans, making it easier to stay engaged and follow through on treatment.
We build tools that make care smarter and more human. Tools that save time, simplify decisions, and strengthen the connection between practitioner and patient. When everything practitioners need is in one place, they can focus on what matters most: helping people get better.
🎟️ This is your invitation.
Bring your ideas. Bring your grit. Bring your care for people.
Join us and shape the future of care.
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. This position supports regulatory operations spanning FDA, FTC, Health Canada, CFIA, CLIA, and other relevant frameworks, promoting collaboration and continuous improvement across Fullscript’s quality system.
You’ll lead and empower a growing Regulatory team, work collaboratively with Quality, Legal, Distribution, and Brand teams, and provide strategic oversight for regulatory readiness, audits, labeling compliance, and supplier qualification.
With more than 17,000+ SKUs across multiple warehouses, your leadership will help ensure Fullscript maintains its strong record of zero non-conformances as we continue to scale safely and responsibly.
Join us to build the next chapter of Fullscript’s regulatory journey!
What You'll Do:
- 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 the FDA, FTC, Health Canada, CFIA, CLIA, and other authorities.
- Manage and maintain regulatory registrations, facility licensing, and supplier qualifications.
- Partner with internal teams to confirm product labeling and marketing claims across supplements, cosmetics, foods, and diagnostics.
- Collaborate on complaint handling, recalls, and corrective actions in partnership with Distribution, Finance, Customer Experience, and Brand teams.
- Work cross-functionally with Legal, Quality, and Distribution to proactively anticipate regulatory changes and strengthen processes to ensure ongoing improvement and alignment across 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.
What You Bring:
- 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 specific to 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 455-2 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.
Bonus if you have...
- 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, balancing compliance needs with business agility.
- Background in supplier or contract manufacturer auditing, with an eye for continuous improvement and partnership development.
Why You'll Love Fullscript:
- Market competitive compensation package including equity
- 401K matching (within US)//RRSP matching (within CAD)
- Flexible PTO policy
- Flexible benefits package and additional perks
- Employee discount on Fullscript catalog of products for family & friends
- Ability to *Work Wherever You Work Well*
Why Fullscript
Great work happens when people feel supported, trusted, and inspired. You’ll join a team that:
⬦ Values innovation. We stay curious and keep finding smarter ways to make care better.
⬦ Supports growth. We learn together and take on new challenges that drive impact.
⬦ Puts people first. We win as a team and leave egos at the door.
📌 Apply now. Let’s build the future of healthcare together.
A Few Things to Know
We’re grateful for the high level of interest in joining Fullscript. Because of the number of messages we receive, we’re not able to review or respond to individual inquiries about open roles via email, LinkedIn, or other social platforms. Please apply directly through our careers page to ensure your application reaches our hiring team.
Fullscript is an equal opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request. Email accommodations@fullscript.com for support.
All employment offers are contingent upon the successful completion of background checks, conducted in compliance with applicable federal, state, and provincial laws.
We also 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.
Learn More About Fullscript
💬 @fullscriptHQ on instagram
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
