Director of Regulatory Affairs

ARMRA®

Director of Regulatory Affairs leading and scaling ARMRA's regulatory function across product lines. Managing compliance and ensuring regulatory approval for dietary supplements.

Posted 5/12/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Set the strategic direction for ARMRA's regulatory affairs function, anticipating regulatory shifts and proactively positioning the business ahead of change.
Lead, mentor, and develop the Manager of Regulatory Affairs, setting clear goals, providing ongoing feedback, and building a high-performing team culture.
Serve as the senior regulatory voice in cross-functional discussions, advising executive stakeholders on risk, opportunity, and compliance implications of business decisions.
Own the regulatory roadmap, prioritizing initiatives that scale with the business and align with broader company objectives.
Maintain deep expertise in FDA, FTC, and other dietary supplement regulations; translate regulatory developments into clear, actionable guidance for the business.
Provide final review and approval of marketing materials, product labels, and digital content, ensuring claims are substantiated, truthful, and compliant.
Oversee product labeling, including supplement facts panels and allergen declarations, ensuring full FDA compliance (21 CFR 101).
Lead regulatory response to inquiries, audits, and submissions; serve as the primary point of contact with external regulatory bodies and consultants as needed.
Develop, maintain, and continuously improve comprehensive regulatory documentation, including SOPs, raw material specifications, and finished product specifications.
Direct stability testing programs, including protocol design, execution oversight, and final documentation review.
Partner with Quality Assurance to build and maintain cGMP-compliant systems (21 CFR 111) that support ARMRA's scale and complexity.
Embed regulatory thinking early in the product development lifecycle, ensuring compliance from concept through commercialization.
Partner with Marketing, Legal, and Science to align on claims strategy and ensure messaging is both compelling and defensible.
Act as the escalation point for complex regulatory questions raised by the Manager of Regulatory Affairs or other internal stakeholders.
Build relationships with external counsel, consultants, and regulatory bodies to strengthen ARMRA's position and stay ahead of industry trends.

Requirements

What you’ll need

Bachelor's degree in Food Science, Chemistry, Biology, or related field required; advanced degree (M.S., Ph.D., RAC certification, or J.D.) strongly preferred.
8–10+ years of progressive experience in regulatory affairs within the dietary supplement or pharmaceutical industry, with at least 2+ years in a leadership or people-management capacity.
Demonstrated success building or scaling a regulatory function in a high-growth, consumer-facing company.
Deep expertise in FDA regulations (21 CFR 111 and 101) and FTC guidelines as they apply to dietary supplements and marketing claims.
Exceptional written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance for non-technical stakeholders.
Strong analytical and critical thinking abilities; comfortable making judgment calls on ambiguous regulatory questions.
Proven ability to manage multiple priorities, lead through influence, and deliver in a fast-paced environment.
Detail-oriented operator who also thinks strategically about systems, scale, and team development.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsFDA regulationsFTC guidelinescGMP compliancestability testingSOP developmentproduct labelingregulatory documentationrisk assessmentanalytical skills

Soft Skills

leadershipmentoringcommunicationanalytical thinkingstrategic thinkingteam developmentrelationship buildingproblem-solvinginfluencedetail-oriented

Certifications

RAC certificationM.S.Ph.D.J.D.