Director, Regulatory Affairs

October 1

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Seed Health

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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.

51 - 200 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Lead Regulatory & Compliance Function: Manage and oversee Seed’s Regulatory and Compliance activities, building and promoting a strong compliance culture while balancing business objectives and implementation of frameworks across teams. • Strategic Risk Foresight: Apply foresight and predictive modeling to anticipate potential downstream regulatory, scientific, and market issues, enabling proactive risk mitigation and informed business decisions. • Claims & Substantiation: Direct substantiation strategy for all ingredient- and composition-based claims, maintaining a robust dossier with clear guardrails that empower cross-functional teams to develop compliant marketing and product communications. • Oversee Seed's Compliance process: Generating and approving various written content in adherence with the current regulatory and legal landscape and advising on risk mitigation where appropriate. • Clinical & Scientific Translation: Leverage a broad understanding of human physiology to guide the design and interpretation of preclinical and clinical studies, and translate complex outcomes into permissible-consumer facing claims that align with brand positioning. • Regulatory Guidance for Innovation: Provide strategic counsel on product development, formulations, labeling, and claims to enable brand growth, new product launches, and global expansion. • Compliance Oversight: Own and optimize compliance workflows and approval processes, ensuring timely, standardized review of materials while safeguarding against regulatory and reputational risks. • Regulatory Intelligence: Monitor, interpret, and communicate emerging FDA, FTC, NAD/BBB, Prop 65, and global regulatory requirements and enforcement trends; maintain fluency in ODI, NDI, and GRAS designations and related frameworks. • Cross-Functional Enablement: Deliver clear regulatory counsel across teams, fostering organizational awareness of compliance requirements and enabling confident, compliant decision-making. • External Engagement: Collaborate with external consultants, CROs, and regulatory partners as needed to support compliance, certification, and global regulatory pathways. • Product Matters: Advise the business on our expanding line of product offerings as it relates to product claims, ingredients, labels, off-label content, and other applicable matters.

🎯 Requirements

• Minimum of 10 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment (medical devices, natural health products/ dietary supplements/pharmaceuticals). • 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 (including Subpart L) and FSMA. • Strong knowledge of the FDA regulatory landscape and enforcement discretion trends for dietary supplements and previous experience in managing regulatory activities within the dietary supplement industry. • Strong expertise in interpreting and applying FTC regulatory frameworks, including health claims guidance, 16 CFR Part 260, 16 CFR Part 255—as well as relevant enforcement trends and case law. • Strong knowledge of pharmacovigilance activities and risk management activities in relation to dietary supplements. • Previous experience with Proposition 65 compliance and safeguarding. • Previous experience in Complaint Handling and evaluation of Adverse Events/Incidents for reportability to regulatory agencies, including MedWatch (when mandated). • Highly organized with strong attention to detail. • Ability to identify compliance risks and escalate when necessary. • Ability to work and achieve success in an ever-changing, technology-forward fast-paced environment.

🏖️ Benefits

• Health insurance • Dental insurance • Vision insurance • Life insurance • AD&D insurance • Long-term disability insurance • Mental wellness support • Employee assistance program (EAP) • Wellness stipend • 401(k) match • 15 vacation days • 7 sick/safe days • 2 personal days • 10 Recharge Days (Summer + Winter) • 15 paid company holidays • Remote work setup stipend • Quarterly wellness and workplace stipends