Regulatory Affairs Manager in United States at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Manager based in the United States.
This role sits at the intersection of science, compliance, and brand innovation within a fast-evolving consumer health environment. You will ensure that product claims, labeling, and regulatory documentation meet stringent U.S. dietary supplement and FDA/FTC requirements while enabling strong, science-backed storytelling. Working cross-functionally with Brand, Product, Quality, and Marketing teams, you will translate complex regulatory frameworks into clear, actionable guidance. The position plays a key role in safeguarding product integrity across a growing portfolio of microbiome and nutrition-focused innovations. You will help maintain compliance across labeling, claims substantiation, and ingredient documentation while supporting audits and GMP readiness. This is a highly collaborative, detail-driven role suited for someone who thrives in a dynamic, fast-paced, and science-led organization. You will also contribute to process improvements and automation efforts that strengthen regulatory operations at scale.
- Conduct comprehensive regulatory and compliance reviews of ingredients, formulations, packaging, and marketing assets in line with applicable U.S. regulations (including FDA and dietary supplement frameworks)
- Review and validate product labels, structure/function claims, and marketing content to ensure compliance with FTC and FDA substantiation requirements
- Maintain and manage regulatory documentation including ingredient status, allergen declarations, GRAS/NDIN records, and other compliance files
- Act as a key regulatory liaison for cross-functional teams, providing timely guidance and clear compliance pathways for Brand, Creative, and Marketing requests
- Support GMP compliance activities including review of QMS documentation, change controls, specifications, and audit readiness materials
- Contribute to the development and optimization of SOPs, workflows, and automation initiatives to improve regulatory efficiency and scalability
- Minimum 6 years of Regulatory Affairs experience in a GMP environment, with at least 4 years focused on dietary supplement regulatory reviews in the U.S.
- Bachelor’s degree in pharmaceutical, nutritional, life sciences, or related scientific field
- Strong knowledge of FDA dietary supplement regulations (including 21 CFR 111) and FSMA requirements
- Solid understanding of FTC advertising standards and structure/function claim compliance
- Experience with GMP documentation, labeling requirements, and regulatory substantiation practices
- Proven ability to collaborate in cross-functional teams and communicate regulatory guidance effectively
- Strong attention to detail, analytical thinking, and ability to manage multiple priorities in a fast-paced environment
- Preferred: experience with probiotic or live microbial products, and familiarity with international regulatory frameworks (EU, Canada, Australia)
- Competitive salary range of $130,000–$150,000 annually, plus equity and comprehensive benefits
- 100% remote work within the United States
- Medical, dental, and vision insurance with multiple plan options and employer contributions
- Mental health support including therapy sessions, coaching, and digital wellness tools
- 401(k) plan with employer match and immediate vesting
- Generous parental leave and phased return-to-work options
- Flexible paid time off, including vacation, sick days, personal days, recharge days, and company holidays
- Home office and wellness stipends to support remote work and well-being
- Learning, development, and additional lifestyle benefits including pet insurance and disability coverage.