Senior Director, Regulatory, Quality, and Product Development - #251917

Summary

We are seeking a Senior Director of Regulatory, Quality, and Product Development that will oversee the development, implementation, and management of comprehensive compliance and quality assurance programs, while also leading strategic product development and improvement initiatives to drive innovation and ensure alignment with Dr. Merola’s vision. This role ensures that organizational policies, procedures, and operations adhere to regulatory standards, industry guidelines, and internal quality benchmarks. The Senior Director will lead audits, risk assessments, and corrective action plans while fostering a culture of compliance and continuous improvement. They will collaborate cross-functionally to maintain certifications, mitigate risks, and drive quality excellence across all processes. The ideal candidate is a strategic leader with deep expertise in regulatory compliance, quality assurance, and operational integrity.

Key Responsibilities & Duties

• Regulatory Affairs Leadership
• Develop and lead regulatory strategies for new product approvals in domestic and international markets.
• Manage end-to-end regulatory submissions and maintain compliance with applicable regulations.
• Provide strategic regulatory guidance on filings, testing, labeling, and claims substantiation.
• Stay current on regulatory trends and proactively advise leadership on impacts to product specifications or operations.
• Build effective relationships with health authorities such as the FDA, and lead responses to regulatory inquiries or inspections.
• Understand and ensure compliance with export/import regulations.
• Quality Assurance & Risk Management
• Ensure quality systems align with cGMPs, FDA, EU GxP, and ICH regulations.
• Oversee internal audits, risk assessments, CAPAs, and documentation practices.
• Champion a culture of quality and continuous improvement throughout the organization.
• Maintain certifications and quality standards across supply chain, production, and development teams.
• Product Strategy & Development
• Set product development priorities and timelines, ensuring alignment with strategic goals.
• Collaborate across R&D, regulatory, manufacturing, and sales to deliver product innovation.
• Define and refine product vision, integrating customer insights and market trends.
• Track KPIs and performance metrics to evaluate product success and impact.
• Team Leadership & Collaboration
• Lead and mentor teams in regulatory affairs, quality, product development, and supply chain.
• Foster a collaborative, inclusive team culture that promotes professional development.
• Influence cross-functional stakeholders to ensure alignment and execution of regulatory and quality priorities.
  
  

Requirements/Qualifications

• Education
• B.S./B.A. in a scientific discipline required; advanced degree preferred.
• Experience
• 12+ years of experience in Regulatory Affairs and/or Quality Assurance within supplements or sports nutrition, including 5+ years in leadership roles.
• Direct experience with regulatory inspections and health authority communications.
• Technical & Regulatory Knowledge
• Expert understanding of cGMPs, FDA, EU GxP, and ICH regulations.
• Proficiency with regulated e-systems and compliance platforms.
• Leadership & Communication
• Proven leadership in cross-functional, matrixed environments.
• Excellent written and verbal communication skills.
• Skilled in mentoring, team building, and influencing across all levels.
  
  

WORK ENVIRONMENT & TRAVEL

• This position is hybrid, requiring a balance of remote work and on-site presence based on business needs.
• Flexibility to travel as needed for regulatory meetings, audits, and team collaboration.
• Occasional extended hours may be required during critical project deadlines or inspections.