Job Description

A rapidly growing health and wellness company focused on science-driven innovation, premium quality standards, and practitioner-supported nutritional products is seeking a Chief Science, R&D, Quality & Regulatory Officer to join its executive leadership team.

The company develops specialized nutrition and condition-specific supplement products designed to support both consumers and healthcare practitioners through clinically informed solutions.

The Opportunity

The Chief Science, R&D, Quality & Regulatory Officer will serve as the executive leader responsible for the organization’s scientific strategy, product integrity, quality systems, and regulatory compliance.

Reporting directly to the CEO, this individual will lead and integrate Scientific Affairs, Clinical Research, R&D, Quality Assurance, and Regulatory Affairs into a unified function that supports innovation, compliance, and long-term growth.

This role combines executive leadership with hands-on scientific and regulatory engagement, including oversight of clinical initiatives, FDA interactions, quality systems, and scientific substantiation efforts.

Key Responsibilities

Executive & Scientific Leadership

• Serve as a key member of the executive leadership team, contributing to strategic planning, investment decisions, and risk management.
• Provide scientific leadership supporting product innovation, brand positioning, and commercial strategy.
• Lead, mentor, and develop cross-functional teams across Scientific Affairs, R&D, Quality, and Regulatory.
• Represent the company with regulatory agencies, scientific organizations, industry associations, and external partners.

Clinical & Scientific Affairs

• Lead clinical affairs strategy including study design, execution, and reporting to support product claims and innovation.
• Establish SOPs and ensure scientific rigor across clinical and substantiation activities.
• Oversee validation studies, protocol development, statistical analysis, and scientific reporting.
• Serve as the primary scientific SME for internal teams and external stakeholders.

Education & Thought Leadership

• Oversee development of scientific publications, whitepapers, presentations, and educational materials.
• Build practitioner education initiatives and HCP engagement resources.
• Partner with commercial teams on scientific review of marketing materials and practitioner strategy.

Research & Development

• Identify emerging ingredient and category trends to guide innovation strategy.
• Oversee formulation development and product pipeline execution.
• Partner cross-functionally to ensure products are scalable, manufacturable, and commercially aligned.

Quality Assurance

• Lead company-wide quality systems and cGMP compliance efforts (21 CFR 111).
• Oversee CAPA, investigations, recalls, audits, and supplier quality programs.
• Build a proactive quality culture focused on prevention and continuous improvement.

Regulatory Affairs

• Ensure compliance with FDA, FTC, USDA, and applicable international regulations.
• Serve as primary liaison with regulatory agencies and industry organizations.
• Oversee regulatory submissions, product claims substantiation, and labeling compliance.
• Monitor evolving regulations and implement forward-looking compliance strategies.

Qualifications

Experience & Education

• Advanced degree strongly preferred (PhD, PharmD, MD, or equivalent); Master’s degree required.
• 10–15+ years of progressive leadership experience within dietary supplements, nutrition, consumer health, or pharmaceutical industries.
• Strong background across clinical research, scientific affairs, quality, and regulatory leadership.
• Experience managing FDA inspections, regulatory correspondence, and compliance matters.

Technical Expertise

• Deep knowledge of dietary supplement regulations including:
  • 21 CFR 111 cGMP
  • DSHEA
  • FTC substantiation requirements
  • Labeling and claims compliance
• Strong expertise in clinical study design, GCP, and scientific substantiation.
• Excellent scientific writing, communication, and presentation skills.

Leadership Profile

• Strategic scientific leader with strong executive presence.
• Collaborative, cross-functional operator capable of scaling teams and systems.
• Calm and decisive under pressure with strong ethical judgment and commitment to consumer safety.