Core Duties and Responsibilities:
- Lead global regulatory strategy for product launches, reformulations, claims, and market expansion initiatives.
- Serve as the central point of coordination between U.S. regulatory requirements and international market execution.
- Maintain visibility over global registrations, renewals, submissions, and market-specific requirements.
- Identify and resolve regulatory risks before they impact launch timelines or business objectives.
- Monitor regulatory developments and translate changes into actionable business guidance.
- Partner with Product Development to evaluate ingredients, formulations, and claims early in development.
- Collaborate with Marketing to ensure claims and promotional materials are compliant and substantiated.
- Act as a trusted advisor to Product Development, Purchasing, Quality, and Customer Support teams.
- Drive communication across functions to improve speed-to-market and eliminate regulatory bottlenecks.
- Oversee regulatory submissions, certifications, registrations, and notifications.
- Review and approve labels, claims, promotional materials, and compliance-sensitive content.
- Ensure compliance with Health Canada, European Union, and other applicable international regulations.
- Manage relationships with external consultants and regulatory partners supporting global market access.
- Provide leadership, coaching, and development for direct reports.
- Serve as an escalation point and technical resource for complex regulatory issues.
- Foster a collaborative, solutions-oriented regulatory culture.
- Up to 25% travel with limited local driving required at times.
- 2 onsite days per week is an essential function of this position.
- Additional duties as assigned.
Position Requirements:
- Bachelor's degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, or related field.
- 5+ years of regulatory compliance experience in dietary supplements or similar regulated industry.
- Advanced knowledge of FDA, DSHEA, cGMP, Health Canada, EU, and global market-entry requirements.
- Experience supporting international product registrations and commercialization activities.
- Strong communication, project management, analytical, and stakeholder management skills.
- Ability to influence cross-functional teams and translate regulations into practical business solutions.
- Proficiency with Microsoft Office applications.
