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International Regulatory Affairs Director

Keystone & Golden, Inc.
San Jose, United Statesfull_timeVerifiedPosted 30 Jan 2025

About the role

An industry-leading nutraceutical company is seeking an International Regulatory Director to lead and manage regulatory compliance for dietary supplements, food, homecare, and skincare products across global markets, including the U.S. This role is responsible for ensuring compliance with international regulations, managing product registrations, and staying ahead of evolving regulatory landscapes. The ideal candidate will bring deep expertise in global regulatory affairs and the ability to lead a team in navigating complex compliance challenges.

Key Responsibilities:

  • Lead international regulatory compliance efforts, ensuring adherence to regulations in Europe, Africa, North America, and other key markets.
  • Oversee and execute regulatory submissions, registration dossiers, and labeling compliance for new and existing products.
  • Conduct regulatory pathway assessments for new product development and market entry strategies.
  • Collaborate with Product Development, Marketing, Quality, and Operations teams to align regulatory requirements with business goals.
  • Review and approve product labels, marketing materials, and digital content for compliance with FDA, FTC, and NAD guidelines.
  • Work with external legal counsel to evaluate claims, supplement facts, and nutrition labeling.
  • Identify potential regulatory risks and proactively develop solutions to maintain compliance in all international markets.
  • Train and mentor regulatory team members, ensuring continuous knowledge development and best practices.
  • Serve as the primary liaison for regulatory inspections and international product certifications (e.g., NSF, Organic, Halal).

Qualifications & Experience:

  • B.S. in a science-related field (Regulatory Affairs Certification preferred).
  • 5+ years of experience in international regulatory affairs within the dietary supplement, food, or personal care industries.
  • In-depth knowledge of DSHEA, FDA 21 CFR 100s, FTC, NAD, and global regulatory frameworks.
  • Proven ability to assess and mitigate regulatory risks in international markets.
  • Strong problem-solving, leadership, and cross-functional collaboration skills.
  • Detail-oriented with excellent written and verbal communication abilities.
  • Ability to thrive in a fast-paced, deadline-driven environment.

This is a high-impact role for a strategic regulatory leader looking to shape global compliance strategies while driving business success.

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Company

Keystone & Golden, Inc.

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