[Remote] Senior Regulatory Manager, Quality at Fullscript

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Healthcare Platform, Supplements, Cosmetics, Diagnostic Test Kits, Food ProductsIndustries

Requirements

10+ years of regulatory compliance experience, including 5+ years in a management role
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
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

Responsibilities

Lead and mentor the Regulatory team
Oversee regulatory operations and readiness for audits and inspections
Manage and maintain regulatory registrations, facility licensing, and supplier qualifications
Partner with internal teams to confirm product labeling and marketing claims
Collaborate on complaint handling, recalls, and corrective actions
Work cross-functionally to proactively anticipate regulatory changes and strengthen processes
Provide regulatory oversight for diagnostic laboratories and self-collection testing kits
Monitor and report on key regulatory KPIs

Skills

Key technologies and capabilities for this role

Regulatory StrategyFDAFTCHealth CanadaCFIACLIAAuditsLabeling ComplianceSupplier QualificationRegulatory ReadinessTeam LeadershipRegulatory Operations

Questions & Answers

Common questions about this position

What experience is required for the Senior Regulatory Manager role?

Candidates need 10+ years of regulatory compliance experience, including 5+ years in a management role overseeing regulatory professionals, plus deep knowledge of U.S. and Canadian regulations for dietary supplements, foods, cosmetics, diagnostics, OTCs, and medical devices.

What does the Regulatory team do at Fullscript?

The team leads regulatory strategy, ensures compliance across supplements, cosmetics, diagnostic test kits, and food products, and handles operations for FDA, FTC, Health Canada, CFIA, CLIA, including audits, labeling, supplier qualification, and complaint handling.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What kind of company culture does Fullscript have?

Fullscript fosters a culture of ownership, accountability, and professional growth, emphasizing collaboration across teams like Quality, Legal, Distribution, and Brand, while valuing ideas, grit, and care for people to build a healthier future.

Fullscript

Platform for managing supplement plans

About Fullscript

Fullscript provides a platform for healthcare practitioners to create and manage supplement plans for their patients. The platform simplifies the workflow for health professionals, allowing them to personalize treatment plans with custom protocols and features. It serves over 70,000 practitioners, including doctors and nutritionists, and operates in a two-sided market by selling high-quality supplements directly to patients or in-office, with prices set by the practitioners. Fullscript also offers educational resources to help patients adhere to their supplement plans, including infographics, handouts, and an award-winning blog covering various wellness topics. The company's goal is to improve patient outcomes and make wellness more affordable through better support and resources for both practitioners and patients.

Ottawa, CanadaHeadquarters

2011Year Founded

$265.7MTotal Funding

LATE_VCCompany Stage

Education, Healthcare, Consumer GoodsIndustries

501-1,000Employees

Benefits

Flexible Paid Time Off

Stock Options

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Remote Work Options

Wellness Program

Training Budget

Risks

Integration challenges with Rupa Health could lead to operational inefficiencies.

Regulatory scrutiny may arise from handling genetic data with 3X4 Genetics.

Recent executive changes could cause strategic misalignments during transitions.

Differentiation

Fullscript offers a seamless blend of virtual dispensing and in-office sales.

The platform supports over 70,000 practitioners with personalized treatment plans.

Fullscript's educational resources enhance patient adherence and promote wellness.

Upsides

The acquisition of Rupa Health expands Fullscript's comprehensive care platform.

Partnership with 3X4 Genetics enhances personalized supplement recommendations.

Growing demand for telehealth boosts Fullscript's digital health platform.

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