Prodrome Science · 2 weeks ago
VP of Regulatory of Affairs
Temecula, CA
Full-time
Onsite
Director/Executive
10+ years expProdrome Science is seeking a Vice President of Regulatory Affairs who will develop and lead the organization’s regulatory strategy across all products and clinical operations. This senior executive will ensure compliance with federal and state regulations while driving regulatory submissions and supporting company expansion into new markets.
Dietary SupplementsMedical
Responsibilities
Develop and execute the company’s regulatory strategy for new and existing products
Serve as the primary regulatory advisor to the CEO and executive team
Oversee regulatory planning for product launches, clinical trials, labeling, marketing claims, diagnostics, and wellness products
Ensure alignment between Regulatory, QA, Clinical, R&D, Marketing, and Operations
Ensure compliance with: FDA (DSHEA, 510(k), PMA), HIPAA, CLIA, FTC, and state-specific regulations
Oversee regulatory audits, inspections, and interactions with federal/state agencies
Maintain up-to-date knowledge on evolving laws and communicate changes to leadership
Develop and maintain SOPs, regulatory documentation, and quality frameworks
Lead and approve all regulatory submissions, including 510(k), IND, PMA, GRAS, clinical protocols, and labeling packages
Oversee the creation, review, and approval of technical files, risk assessments, and validation reports
Ensure accuracy of all product claims, marketing language, and scientific communications
Work closely with R&D and Clinical teams to ensure regulatory considerations are integrated early in development
Partner with Quality Assurance to ensure audit readiness, corrective actions, and continuous improvement
Support Commercial, Sales, and Marketing with compliant messaging and training
Represent the company to regulatory bodies, external partners, and medical experts
Build, lead, and mentor a high-performing regulatory team
Set team KPIs aligned with business priorities
Provide regulatory training across departments
Qualification
Required
Master's degree in a scientific field
10+ years of progressive regulatory experience in biotech, diagnostics, supplements, life sciences, or medical devices
Deep knowledge of FDA, CLIA, HIPAA, GMP, GLP, and quality management systems
Proven experience leading regulatory submissions and regulatory strategy
Strong leadership, communication, and cross-functional collaboration skills
Ability to thrive in an innovative, fast-moving, science-driven environment
Preferred
PhD or PharmD
Company
Prodrome Science
A disease prodrome is the dysfunctional biochemical state that appears in your body before you get a disease and is the cause of that disease.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Dayan Goodenowe
Founder, President and CEO
Recent News
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