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Fullscript

Senior Regulatory Manager, Quality

Fullscript, Boston, Massachusetts, us, 02298

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Senior Regulatory Manager, Quality

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Fullscript

Founded in 2011, 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 count on us for access to high‑quality supplements, industry‑leading labs, and tools that make it easier to 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.

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

401(k) 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?

⬦ Values innovation—we push boundaries and always look for better ways.

⬦ Supports growth—through learning, mentorship, and meaningful work.

⬦ Cares about balance—with flexible work options and time off when you need it.

Apply now—let’s build the future of healthcare, together.

Fullscript is an equal‑opportunity employer committed to creating an inclusive workplace. Accommodations are available upon request—email accommodations@fullscript.com for support.

Before joining the team, all candidates who receive and accept an offer will complete a background check.

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.

MORE INFO: www.fullscript.com

SOCIAL: @fullscriptHQ

Let’s make healthcare whole

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