This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.
The International Regulatory Director is responsible for ensuring regulatory compliance across all international markets, including the United States, for a company’s portfolio of products—such as dietary supplements, food items, homecare goods, and skincare lines. This role oversees an international regulatory team and stays ahead of regulatory changes and challenges in each country.
The position is part of the broader Product, Science, and Technology team, with a focus on managing regulatory documentation, interpreting requirements, and supporting international teams in a timely and professional manner.
Key Responsibilities
Collaborate with Product Development, Marketing, Quality, and Operations to share and interpret relevant regulatory information
Conduct regulatory pathway assessments for new products in various global markets
Lead regulatory submissions and manage timelines for product registrations
Review product labels for compliance and accuracy
Partner with cross-functional teams on product development and renovations
Provide regulatory strategies and solutions to support successful product launches
Assist in preparing substantiation for product claims in the U.S.
Review marketing materials, digital content, and communications to assess compliance with applicable U.S. regulations (FDA, FTC, NAD)
Identify and resolve regulatory issues and ensure compliance across regions
Coordinate with legal counsel on product claims, supplement/nutrition facts, and labeling
Liaise with international partners on claims and labeling requirements
Train and mentor regulatory staff to develop knowledge and skills
Competencies for Success
Strong knowledge of DSHEA, FDA 21 CFR regulations, FTC and NAD guidelines
Experience with international regulatory frameworks, especially in Europe and Africa
Ability to identify regulatory risks and communicate proactively with leadership
Analytical and systematic problem-solving skills
Creative and solution-focused mindset
Strong written and verbal communication abilities
Transparent and collaborative communicator
Highly detail-oriented and organized
Flexible and adaptable in a fast-paced environment
Patient, approachable, and team-oriented
Able to perform under pressure and committed to ongoing learning
Measures of Success
Consistently meets project deadlines and deliverables
Positive feedback from internal teams and external partners
Strong working relationships across departments and with global stakeholders
Education & Experience
Bachelor’s degree in a science-related field
Minimum 5 years of experience in an international regulatory role
Regulatory Affairs Certification (RAC) is a plus
Physical Demands & Work Environment
Ability to sit, stand, walk, bend, kneel, and lift up to 20 pounds
Frequent use of computers and telephones
Requires close, distance, peripheral vision and depth perception
Moderate noise environment
Reasonable accommodations will be made for individuals with disabilities
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