Director, Regulatory Affairs

You

As a Director of Regulatory Affairs, you’ll steward our content and processes allowing for their fullest expressions, while maintaining our reputation for scientific integrity and compliance. You’ll seamlessly steer and guide teams across our organization with your knowledge, insights, and professional advice to mitigate risks in a complex and ever-evolving regulatory and legal landscape. Your judgment is sharp, decisive, and backed with deep industry knowledge and varied real-world experience.

As Director of Regulatory Affairs, you’ll lead and shape Seed’s global regulatory and compliance strategy, ensuring scientific integrity, risk mitigation, and adherence to evolving regulatory frameworks. You’ll manage both day-to-day compliance activities and longer-term strategic initiatives, collaborating cross-functionally to support product innovation, brand growth, scientific rigor, international expansion, and organizational evolution.

This role requires someone well adept at navigating complex regulatory gray areas—an experienced, decisive, and judicious professional who can balance innovation with compliance in the dietary supplement industry. You’ll be a critical steward of Seed’s reputation, ensuring our science and messaging are both compelling and compliant.

Responsibilities

• 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.
  • Provide guidance and advice on marketing and advertising of our products, including health claims, in adherence with FTC policy and congruent with NAD/BBB case decisions.

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.

Additionally, we’d like to see:

• Experience working with live microbials / probiotic products, including manufacturing (CMC), analysis / methodologies, stability, taxonomy, delivery methods, mechanisms of action, and various health outcomes
• Experience in working through litigation matters.
• Experience in working through a response to a complaint filed through the NAD/BBB.
• Experience managing 483s and FDA warning letters 
• Experience resolving consumer watchdog challenges
• Experience in international regulations, including EU, CAN (PLA and NPN registrations for Natural Health Products) and AUS, amongst other jurisdictions.

The annual pay range for this full-time position is $200k-$240k + performance-based bonus + equity + benefits across all US locations (this position is 100% remote-US). Our pay ranges are guided by discipline, level and experience required. Within the range, individual pay may vary based on additional factors, including: your specific location, desired skills/ technical competency, relevant experience and advanced education/ training.Benefits include: Medical, Dental, Vision, Life, AD&D, LTD, Mental Wellness, EAP, Wellness Stipend + 401(k) match.