Manager, Global Regulatory Compliance
About The Position
This role is responsible for leading global regulatory strategy for product launches, reformulations, claims, and market expansion initiatives. The position serves as a central point of coordination between U.S. regulatory requirements and international market execution, maintaining visibility over global registrations, renewals, submissions, and market-specific requirements. The manager will identify and resolve regulatory risks, monitor regulatory developments, and translate changes into actionable business guidance. This role involves partnering with Product Development to evaluate ingredients, formulations, and claims, and collaborating with Marketing to ensure claims and promotional materials are compliant and substantiated. The manager will act as a trusted advisor to various teams, drive cross-functional communication to improve speed-to-market, and oversee regulatory submissions, certifications, registrations, and notifications. Additionally, the role includes reviewing and approving labels, claims, and promotional materials, ensuring compliance with international regulations, managing external consultants, and providing leadership, coaching, and development for direct reports. The position also serves as an escalation point and technical resource for complex regulatory issues, fostering a collaborative culture.
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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
