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PrismHR · 1 day ago

QDS Regulatory Manager

Florida, United States

Full-time

Onsite

Senior Level, Lead/Staff

12+ years exp

PrismHR is seeking a Regulatory Manager to lead Regulatory Excellence in Consumer Health. This role involves managing the full lifecycle of quality documentation and ensuring compliance with federal regulations while serving as a strategic advisor within the Quality Development Services team.

Cloud ComputingHuman ResourcesSaaSSoftware

Growth Opportunities

Hiring Manager

Emily Cotes

Responsibilities

Lead the preparation and submission of regulatory documentation for agencies and commercial partners, including SOPs, quality agreements, and professional opinions

Conduct rigorous formulation reviews, marketing copy audits, and regulatory due diligence to ensure all products meet market-entry standards

Design and develop controlled documentation, including Safety Data Sheets (SDS), investigational reports, and study protocols

Write and review FSMA/HARPC plans and lead cGMP facility audits as directed

Maintain and control regulatory databases to ensure all files are audit-ready and compliant with national requirements

Evaluate regulatory changes affecting client products and methodologies, providing proactive guidance on risk mitigation

Provide leadership with strategic guidance on regulatory operations and compliance strategies

Operate seamlessly within a remote team using project management software to ensure traceability, accountability, and accurate billable time reporting

Represent the firm at tradeshows and conferences to maintain a pulse on industry trends and regulatory shifts