Regulatory Affairs Manager

Role overview

This opportunity is for a Regulatory Affairs Manager in the United States, hired through a partner company that handles the application process and all subsequent steps. The role operates at the crossroads of regulatory science, compliance, and brand development in a rapidly changing consumer health setting. You will help ensure that product claims, labeling, and supporting documentation align with U.S. dietary supplement rules and FDA/FTC expectations, while still enabling clear, science-based messaging.

Working closely with Brand, Product, Quality, and Marketing, you will turn complex regulatory requirements into practical guidance that teams can use. The position supports product integrity across a growing portfolio focused on microbiome and nutrition-related innovation. It also contributes to compliance across labeling, claim substantiation, ingredient records, and audit preparedness, while helping improve processes and automation for more scalable regulatory operations.

Accountabilities

• Carry out detailed compliance assessments of ingredients, formulas, packaging, and marketing materials against relevant U.S. regulatory requirements, including FDA and dietary supplement rules.
• Check product labels, structure/function statements, and promotional copy to confirm they meet FDA and FTC substantiation standards.
• Organize and maintain regulatory records such as ingredient status files, allergen disclosures, GRAS/NDIN documentation, and other compliance materials.
• Serve as a regulatory point of contact for cross-functional partners, offering timely guidance and clear paths to compliance for Brand, Creative, and Marketing requests.
• Assist with GMP readiness by reviewing QMS documents, change control records, specifications, and audit-support materials.
• Help improve SOPs, workflows, and automation efforts that increase efficiency and support scaling of regulatory processes.

Requirements

• At least 6 years of Regulatory Affairs experience in a GMP setting, including a minimum of 4 years handling U.S. dietary supplement regulatory reviews.
• A bachelor’s degree in pharmaceutical, nutritional, life sciences, or another related scientific discipline.
• Strong working knowledge of FDA dietary supplement regulations, including 21 CFR 111, along with FSMA requirements.
• Good understanding of FTC advertising rules and requirements for structure/function claim compliance.
• Hands-on experience with GMP documentation, labeling rules, and regulatory substantiation practices.
• Ability to work effectively across functions and communicate regulatory direction clearly.
• Excellent attention to detail, analytical skills, and the ability to juggle multiple priorities in a fast-moving environment.
• Preferred background in probiotic or live microbial products, plus familiarity with international regulatory systems such as those in the EU, Canada, and Australia.

Benefits

• Annual compensation in the range of $130,000 to $150,000, along with equity and a comprehensive benefits package.
• Fully remote arrangement within the United States.
• Medical, dental, and vision coverage with several plan choices and employer contributions.
• Mental health support that may include therapy sessions, coaching, and digital wellness resources.
• 401(k) plan with employer matching and immediate vesting.
• Substantial parental leave plus a phased transition back to work.
• Flexible paid time off, including vacation, sick leave, personal days, recharge days, and company holidays.
• Home office and wellness allowances to support remote working and overall well-being.
• Learning and development support, plus additional lifestyle perks such as pet insurance and disability coverage.

Additional information

This role is posted on behalf of a partner organization, which will manage the application review and next steps. Applications are evaluated using an AI-assisted matching process designed to review candidates fairly and quickly against the role’s core requirements. The shortlist is then passed to the hiring company for interviews, assessments, and final decisions.

Privacy notice

By submitting an application, you consent to the processing of personal data for candidate evaluation and sharing relevant information with the hiring employer under applicable data protection laws, including GDPR where relevant. You may request access, correction, deletion, or objection to processing at any time. AI tools may be used to support parts of the hiring workflow, such as application review, resume analysis, or identifying potential inconsistencies in submitted information, but final hiring decisions are made by humans.