Description
Salary Range: 120,000k - 135,000k
About Designs for Health
Designs for Health is a trusted leader in the nutraceutical industry, known for delivering high-quality, research-driven nutritional products that support better health outcomes. For more than 30 years, we have combined scientific integrity, innovation, and a strong commitment to quality to earn the confidence of practitioners and customers alike.
Job Summary
Designs for Health is seeking a US Regulatory Manager to lead day-to-day US regulatory compliance for dietary supplements and cosmetics and manage a team of 1-2 regulatory professionals. Reporting to the Global Regulatory Affairs Director, this role translates federal and state requirements into practical guidance across the product lifecycle. The manager partners with Legal, Research and Development, Quality, Marketing, and Operations on ingredient and formulation review and permissibility, labeling, scientific substantiation, regulatory notifications and listings, post-market safety, and inspections. Success requires hands-on regulatory work, sound judgment, clear communication, disciplined documentation, and thoughtful people leadership.
Key Responsibilities
- Manage, coach, and develop the US Regulatory team; set priorities, assign work, provide timely feedback, and build capability in partnership with the Global Regulatory Director.
- Maintain clear regulatory procedures, decision records, submission files, trackers, and other inspection-ready documentation that support consistent execution and accountability.
- Monitor relevant federal and state legislative, regulatory, and enforcement developments; assess business impact and translate changes into practical action plans for stakeholders.
- Advise leaders and cross-functional partners on regulatory issues, options, and recommended paths forward, collaborating effectively with the Global Regulatory Director and Legal as appropriate.
- Manage regulatory review of product formulations, labels and labeling throughout the US product lifecycle.
- Evaluate scientific literature, clinical research, and the totality of evidence supporting product safety; partner with Research and Development, Marketing, and Legal to align labeling with FDA and FTC expectations.
- Oversee ingredient permissibility and safety assessments, including documentation of identity, conditions of use, exposure, and applicable GRAS or new dietary ingredient considerations.
- Prepare, review, or coordinate applicable US regulatory submissions and records, such as GRAS notifications, new dietary ingredient notifications, dietary supplement structure/function claim notifications, and cosmetic facility registrations or product listings, as required.
- Manage dietary supplement and cosmetic adverse-event intake, assessment, documentation, follow-up, trend review, escalation, and required reporting within applicable timelines.
- Support FDA inspections, third-party audits, and any potential market action by coordinating accurate regulatory information, responses, and follow-through with Quality, Legal, and Operations.
- Assess the regulatory impact of proposed ingredients, supplier, formulation, manufacturing, and labeling changes before implementation.
- Monitor applicable state requirements, including California Proposition 65 and relevant product or packaging stewardship obligations, and coordinate cross-functional ownership of compliance actions.
- Represent Designs for Health in relevant trade-association or industry activities and communicate emerging positions and standards to internal stakeholders.
- Develop and deliver practical regulatory training for teams whose work affects product compliance or external communications.
Competency
- Regulatory Judgment: Understands complex requirements, evaluates issues in context, and recommends practical, well-supported paths forward.
- Scientific and Technical Rigor: Evaluates safety, claims, and research evidence carefully and documents conclusions clearly.
- People Management: Sets clear expectations, coaches effectively, and creates accountability while supporting team growth.
- Communication and Influence: Explains regulatory issues in plain language and builds alignment across technical and non-technical teams.
- Planning and Execution: Organizes competing priorities, maintains reliable records, and delivers accurate work within regulatory and business timelines.
- Collaboration: Works constructively with Legal, Research and Development, Quality, Marketing, Operations, and external partners.
- Continuous Learning: Maintains current knowledge of regulations, enforcement trends, science, and industry practices and applies new information thoughtfully.
Qualifications
- Bachelor's degree in nutrition, food science, regulatory affairs, toxicology, chemistry, biology, pharmacy, or a related scientific field, or a comparable combination of education and directly relevant experience.
- 5+ years of progressive US regulatory affairs experience, including experience independently managing complex work across the product lifecycle.
- Demonstrated people-leadership experience, including prioritizing work, coaching team members, and maintaining accountability for quality and deadlines.
- Strong working knowledge of US requirements affecting dietary supplements, including the FD&C Act and DSHEA, 21 CFR Parts 101 and 111, and FDA and FTC expectations for labeling, claims, and scientific substantiation.
- Hands-on experience reviewing ingredients, formulations, labels, and scientific evidence and translating findings into clear, documented recommendations.
- Experience with post-market safety or adverse-event processes, regulatory inspections or audits, and cross-functional issue management.
- Strong technical writing, project management, analytical, and verbal communication skills, with careful attention to detail.
- Direct dietary supplement or nutraceutical regulatory experience is strongly preferred. Relevant food, cosmetics, consumer health, or pharmaceutical experience may be considered when it includes transferable work in FDA-regulated labeling or claims, ingredient or product safety, post-market surveillance, inspections, submissions, or controlled regulatory documentation.
- Preferred experience with new dietary ingredient notifications, GRAS evaluations, structure/function claim notifications, MoCRA requirements, California Proposition 65, or applicable state product and packaging requirements.
- An advanced scientific degree, Regulatory Affairs Certification, Certified Nutrition Specialist credential, or Registered Dietitian Nutritionist credential is preferred when relevant to the role's scientific and technical responsibilities.
Benefits
- You receive a competitive salary and performance-based incentives.
- You benefit from health, dental, and vision insurance plans.
- You receive a monthly product stipend to support your personal health journey.
- You have access to paid time off and company holidays.
- You work in a collaborative and supportive team environment.
Physical Demands
This position is primarily sedentary, requiring regular computer use and communication. Some tasks may involve moving within the office environment or occasional lifting of up to 20 lbs. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.
Privacy
Your application for this position is subject to Designs for Health's Privacy Notice for Job Applicants and Workforce Members. Designs for Health does not sell your personal information, nor does Designs for Health share it for purposes of cross-context behavioral advertising.
Our Commitment to Diversity, Inclusion & Belonging
Designs for Health is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment where all employees can grow and thrive. Our employees form meaningful and often life-long connections while working at Designs for Health. We are all passionate about our mission of designing a well world, together.
Reports To
Global Regulatory Affairs Director
#LI-KJM