Director of Regulatory Affairs
New
US, Monday–Friday EST scheduleFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 8–10+ years
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in Food Science, Chemistry, Biology, or a related scientific field
- 8–10+ years of progressive regulatory affairs experience within the dietary supplement, nutraceutical, or pharmaceutical industries
- Minimum 2+ years of leadership or people management experience
- Deep expertise in FDA regulations (21 CFR 111 and 21 CFR 101)
- Deep expertise in FTC guidelines related to dietary supplement claims and marketing
- Proven success building or scaling regulatory programs
- Strong understanding of cGMP standards and quality systems
- Excellent written and verbal communication skills
- Ability to manage multiple priorities in fast-paced settings
Responsibilities
- Lead and define the strategic direction of the regulatory affairs function
- Monitor evolving FDA, FTC, and dietary supplement regulations
- Oversee the review and approval of marketing materials, product labels, and claims
- Manage product labeling compliance including supplement facts and ingredient declarations
- Serve as the primary regulatory advisor for executive leadership
- Develop and maintain regulatory documentation systems including SOPs
- Lead regulatory interactions related to audits and agency communications
- Partner with Quality Assurance to support cGMP-compliant systems
- Embed regulatory oversight throughout the product development lifecycle
- Mentor and develop regulatory team members
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