Senior Regulatory Manager, Quality
Fullscript
full-time
Posted on:
Location Type: Remote
Location: Remote • Florida, Illinois, Massachusetts, New Hampshire • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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.
Requirements
- 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.
Benefits
- 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**
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceaudit managementregulatory strategycGMPNSF 455-2regulatory operationsperformance insightsfacility licensingsupplier qualificationscomplaint handling
Soft skills
leadershipcommunicationcross-functional collaborationmentoringaccountabilityprofessional growthinfluencing stakeholdersproblem-solvingdecision-makingorganizational skills