Talent.com
Senior Regulatory Manager, Quality
Senior Regulatory Manager, QualityFullscript • Raleigh, NC, US
No longer accepting applications
Senior Regulatory Manager, Quality

Senior Regulatory Manager, Quality

Fullscript • Raleigh, NC, US
22 days ago
Job type
  • Full-time
Job description

Senior Regulatory Manager, Quality

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. This is your invitation. Bring your ideas. Bring your grit. Bring your care for people.

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
  • 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
  • Great work happens when people are supported, challenged, and inspired. Here, you'll be part of a team that : Values innovationwe push boundaries and always look for better ways. Supports growththrough learning, mentorship, and meaningful work. Cares about balancewith flexible work options and time off when you need it. Apply nowlet's build the future of healthcare, together.

    We kindly ask that all applications be submitted directly through our careers page. Due to the high volume of interest, we're not able to respond to individual emails or messages about job postings. If your background aligns with what we're looking for, a member of our team will reach out to you directly.

    Fullscript is an equal-opportunity employer committed to creating an inclusive workplace. Accommodations are available upon requestemail accommodations@fullscript.com 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. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are always made by people. This process complies with privacy and employment laws across Canada and the U.S.

    Create a job alert for this search

    Senior Manager Quality • Raleigh, NC, US

    Related jobs
    Sr. Manager, Regulatory Affairs

    Sr. Manager, Regulatory Affairs

    Chiesi • Cary, NC, United States
    Full-time
    Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries. More than 7,000 employees across the group are united...Show more
    Last updated: 29 days ago • Promoted
    Experienced Rates and Regulatory Consultant

    Experienced Rates and Regulatory Consultant

    ScottMadden • Raleigh, NC, US
    Full-time
    Experienced Rates And Regulatory Consultant.Are you passionate about navigating complex regulatory environments and influencing industry strategies? ScottMadden, a premier management consulting fir...Show more
    Last updated: 30+ days ago • Promoted
    HOSPICE CLINICAL MANAGER - RN

    HOSPICE CLINICAL MANAGER - RN

    Liberty Healthcare Management • Dunn, NC, US
    Full-time
    That is why Liberty Hospice provides our hospice patients with state-of-the-art care and pain management services, delivered by our specially trained staff with emphasis on strength, dignity and co...Show more
    Last updated: 30+ days ago • Promoted
    Director Ambulatory Quality & Population Health Analytics

    Director Ambulatory Quality & Population Health Analytics

    UNC Health Care • Morrisville, NC, United States
    Full-time
    Director of Ambulatory Quality and Population Health Analytics.Become part of an inclusive organization with over 40,000 teammates whose mission is to improve the health and well-being of the uniqu...Show more
    Last updated: 9 days ago • Promoted
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    Teleflex • Raleigh, NC, US
    Full-time
    Senior Regulatory Affairs Specialist.Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments, and submissions for complex projects across multiple business units...Show more
    Last updated: 22 days ago • Promoted
    Research Billing Reviewer

    Research Billing Reviewer

    Advocate Aurora Health • Wake Forest, NC, United States
    Full-time
    Wake Forest University Health Sciences - Academic Office of Clinical Research.Schedule Details / Additional Information : . High School Diploma or GED required; Associates Degree preferred.Minimum of 1-...Show more
    Last updated: 13 days ago • Promoted
    RN Clinical Manager, Home Health

    RN Clinical Manager, Home Health

    CenterWell Home Health • Lillington, NC, US
    Full-time
    Become a part of our caring community and help us put health first.Reports To : Associate Director, Home Health Branch Administrator. This is not a remote or work-from-home position.This position req...Show more
    Last updated: 30+ days ago • Promoted
    Assistant Manager

    Assistant Manager

    Pizza Hut • Lillington, NC, US
    Full-time
    N MAIN ST, Lillington, NC ID#P1-679079-1.Flynn Hut joined the Pizza Hut system in 2021.In 2023, we expanded internationally acquiring Pizza Hut's master franchisee in Australia with 260+ units.Toda...Show more
    Last updated: 30+ days ago • Promoted
    Manager, Regulatory Compliance

    Manager, Regulatory Compliance

    James River Management Company • Raleigh, NC, United States
    Full-time
    Come grow with James River Insurance!.James River Insurance is an excess and surplus lines segment of James River Group Holdings, Ltd. Since 2003, James River has provided thousands of commercial pr...Show more
    Last updated: 9 days ago • Promoted
    Senior Manager, Make / Buy Strategy & Execution

    Senior Manager, Make / Buy Strategy & Execution

    Thermo Fisher • Raleigh, NC, US
    Full-time
    Senior Manager, Make / Buy Strategy & Execution.The Senior Manager, Make / Buy Strategy & Execution is a key leadership role within Thermo Fisher Scientific's Contract Manufacturing & Value Assurance (...Show more
    Last updated: 26 days ago • Promoted
    Locum - MD / DO - BC.BE - Dermatologist - Butner, NC Job

    Locum - MD / DO - BC.BE - Dermatologist - Butner, NC Job

    TinkBird Healthcare Staffing • Butner, NC, US
    Full-time
    Tinkbird is actively searching for a Locum MD / DO Dermatologist for North Carolina.Opportunity Highlights include : Schedule Notes 2 shifts per month for 8 hours days and hours will vary.Show more
    Last updated: 30+ days ago • Promoted
    Risk Adv - Business Cons - Risk Qlty and Reg Comp - Life Science - Manager - Mul Pos - 1657015

    Risk Adv - Business Cons - Risk Qlty and Reg Comp - Life Science - Manager - Mul Pos - 1657015

    EY • Raleigh, NC, US
    Full-time
    Risk Advisor, Business Consulting Risk Quality & Regulatory Compliance (Life Science) (Manager).Assist clients in the Life Science sector to identify, manage, and respond to risks while accelerati...Show more
    Last updated: 15 days ago • Promoted
    SAP Quality Management / Manufacturing Manager - Chemicals Industry

    SAP Quality Management / Manufacturing Manager - Chemicals Industry

    Accenture • Raleigh, NC, United States
    Full-time
    Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries?. The Chemicals Industry is evolving at lightspeed : demand for sust...Show more
    Last updated: 2 days ago • Promoted
    Director, Clinical Quality Assurance

    Director, Clinical Quality Assurance

    Eisai • Raleigh, NC, United States
    Full-time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...Show more
    Last updated: 30+ days ago • Promoted
    GIS Manager

    GIS Manager

    Chesapeake Utilities Corporation • Dunn, NC, United States
    Full-time
    Hybrid Remote - must reside in or be willing to relocate to one of our service territories (DE, MD, PA, OH, VA, NC, GA, FL). The Manager, GIS oversees the team responsible for all GIS related functi...Show more
    Last updated: 30+ days ago • Promoted
    Laboratory Instructor : Biology / Environmental Science Lab

    Laboratory Instructor : Biology / Environmental Science Lab

    Campbell University • Lillington, NC, United States
    Part-time
    Position : Laboratory Instructor- Biology / Environmental Science Laboratory.Department : Biological Sciences.The Department of Biological Sciences utilizes part-time Laboratory Instructors some semest...Show more
    Last updated: 17 days ago • Promoted
    Senior Study Manager

    Senior Study Manager

    Actalent • Cary, NC, US
    Full-time
    We are seeking a dedicated and experienced Senior Study Manager to oversee clinical studies at a global level, particularly a Pan Tumor Phase II study involving multiple indications.This dynamic an...Show more
    Last updated: 30+ days ago • Promoted
    Senior eDiscovery Project Manager

    Senior eDiscovery Project Manager

    Contact Discovery Services LLC • Raleigh, NC, US
    Full-time
    A leading eDiscovery technology and consulting firm headquartered in Washington, DC is looking for a remote Senior Project Manager in the eDiscovery space to administer and manage casework througho...Show more
    Last updated: 22 days ago • Promoted