Director of Regulatory Affairs in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director of Regulatory Affairs in the United States.
This is a high-impact leadership opportunity for an experienced regulatory professional to shape and scale compliance operations within a fast-growing health and wellness organization. The role combines strategic oversight with hands-on regulatory expertise across product development, marketing, quality systems, and operational compliance. You will serve as the key regulatory authority across the business, guiding cross-functional teams through evolving regulatory landscapes while building scalable systems and processes. Working closely with leadership, legal, marketing, science, and quality teams, you will help ensure products and communications remain compliant, scientifically supported, and aligned with industry standards. The position is ideal for someone who thrives in dynamic, mission-driven environments and enjoys balancing strategic leadership with operational execution. This fully remote role offers the opportunity to directly influence organizational growth, product innovation, and long-term regulatory excellence.
- Lead and define the strategic direction of the regulatory affairs function across product lines, marketing activities, and operational initiatives.
- Monitor evolving FDA, FTC, and dietary supplement regulations, translating regulatory changes into actionable business guidance.
- Oversee the review and approval of marketing materials, product labels, digital content, and claims to ensure regulatory compliance and scientific substantiation.
- Manage product labeling compliance, including supplement facts panels, ingredient declarations, and allergen disclosures in accordance with FDA requirements.
- Serve as the primary regulatory advisor for executive leadership and cross-functional teams on compliance risks, opportunities, and strategic decisions.
- Develop and maintain regulatory documentation systems including SOPs, product specifications, raw material documentation, and compliance records.
- Lead regulatory interactions related to audits, submissions, inquiries, and external agency communications.
- Partner closely with Quality Assurance teams to support and strengthen cGMP-compliant systems and operational processes.
- Embed regulatory oversight throughout the product development lifecycle from concept through commercialization.
- Collaborate with marketing, legal, science, and product teams to ensure claims strategies remain compelling, defensible, and compliant.
- Build and maintain relationships with external consultants, legal advisors, and regulatory agencies to support ongoing compliance and industry awareness.
- Mentor and develop regulatory team members while fostering a high-performance and collaborative team culture.
- Bachelor’s degree in Food Science, Chemistry, Biology, or a related scientific field required.
- Advanced degree or professional certifications such as M.S., Ph.D., RAC, or J.D. strongly preferred.
- 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 within regulatory functions.
- Deep expertise in FDA regulations, including 21 CFR 111 and 21 CFR 101, as well as FTC guidelines related to dietary supplement claims and marketing.
- Proven success building or scaling regulatory programs within high-growth consumer-facing organizations.
- Strong understanding of cGMP standards, quality systems, product labeling, and claims substantiation practices.
- Excellent written and verbal communication skills with the ability to simplify complex regulatory concepts for diverse audiences.
- Strong analytical, strategic thinking, and decision-making capabilities in ambiguous or evolving regulatory environments.
- Ability to manage multiple priorities and collaborate effectively across cross-functional teams in fast-paced settings.
- Experience with Canadian and European dietary supplement regulations is considered a strong advantage.
- Prior experience mentoring or developing regulatory professionals is highly desirable.
- Fully remote work environment with standard Monday–Friday EST schedule.
- Opportunity to lead and shape regulatory strategy within a rapidly growing health and wellness company.
- Collaborative, mission-driven culture focused on innovation, resilience, and impact.
- Exposure to cross-functional leadership and strategic business initiatives.
- Professional growth opportunities and leadership development within a high-growth organization.
- Competitive compensation package aligned with experience and expertise.
- Comprehensive healthcare and wellness benefits.
- Supportive and entrepreneurial work environment that values ownership, initiative, and continuous improvement.