Regulatory Affairs Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $130k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Seed Health

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Seed Health is a company pioneering the field of microbiome science to enhance human and planetary health. They focus on understanding and leveraging the rich ecosystem of microorganisms living in and on the human body, known as the microbiome, which plays a crucial role in health and well-being. The company employs advanced computational biology, microbial genomics, and ultra-deep sequencing to explore host-microbe interactions, driving innovation from initial discovery through to commercialization. Seed Health develops and delivers innovative health products, such as prebiotics, probiotics, postbiotics, and synbiotics, to optimize microbiome-related health outcomes across different life stages. The company also emphasizes sustainability, using eco-friendly packaging and engaging in environmental research to address global challenges, reflecting their commitment to a sustainable future. Seed Health collaborates with leading scientists and utilizes cutting-edge technology to facilitate groundbreaking research and applications in areas such as gastrointestinal, dermatological, and metabolic health.

📋 Description

• Support the execution of content and compliance processes. • Collaborate across teams to flag risks, provide regulatory guidance, and keep compliance activities moving. • Contribute to global regulatory and compliance strategy by owning key workstreams across labeling, claims substantiation, ingredient documentation, and product review. • Partner cross-functionally to support product development and brand initiatives. • Conduct ingredient, formula, and packaging compliance reviews according to regulatory frameworks, particularly the U.S. FDCA. • Maintain raw material and formula-level compliance documentation. • Execute compliance reviews consistent with FTC and FDA claims compliance standards. • Serve as day-to-day regulatory contact for Brand, Creative, and Marketing. • Contribute to, review and approve QMS records, particularly labels, formulas, specifications, and change controls. • Integrate Regulatory Affairs into generative AI workflows and maintain accurate customer service messaging.

🎯 Requirements

• Minimum of 6 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment, with at least 4 executing technical regulatory reviews in dietary supplements for the U.S. • Minimum B.Sc. in pharmaceutical, nutritional, or life sciences or a related scientific field. • Experience in attaining and adhering to compliance with FDA regulations, including 21 CFR 111 and FSMA. • Strong knowledge of the FDA regulatory landscape and enforcement discretion trends for dietary supplements. • Experience with structure/function claim compliance and general FTC advertising rules. • Strong knowledge of GMP product documentation requirements. • Strong knowledge of dietary supplement labeling requirements. • Experience representing regulatory positions in cross-functional teams.

🏖️ Benefits

• Medical, Dental, Vision, Life, AD&D, LTD, Mental Wellness, EAP, Wellness Stipend + 401(k) match. • Choose from multiple medical, dental, and vision plans. • Access to top-tier virtual care and a complimentary Aaptiv membership for fitness and mental wellness. • HSA with employer contributions, along with Fullscript discounts for supplements. • 12 free therapy sessions per year, plus coaching, meditation, and access to Spring Health tools. • 401(k) plan featuring a 100% match on the first 3% and 50% on the next 2% of contributions. • Parental Leave Policy includes 18 weeks of fully paid leave. • 15 vacation days, 7 sick/safe days, 2 personal days, 10 Recharge Days, and 15 paid company holidays each year. • $750 one-time remote work setup stipend and ongoing access to a $450 quarterly wellness and workplace stipend via JOON.