Senior Manager, Regulatory Affairs and Compliance
About The Position
The Senior Manager, Regulatory Affairs and Compliance is a cross-functional role that leads Regulatory Affairs and Compliance at Traditional Medicinals. The role establishes regulatory strategy, provides authoritative regulatory guidance, and builds the systems, governance, and capabilities needed to support responsible company growth. It also assumes selected compliance responsibilities currently distributed across the organization as the company develops its compliance operating model. Reporting to the Associate General Counsel, the position partners closely with Quality, Operations, Human Resources, Marketing, Innovation, and Legal. It serves as a strategic advisor to leaders, guides regulatory decisions for products and markets, coordinates compliance activities, supports audit and inspection readiness, and creates scalable processes for a growing consumer health business. The role is based in the Rohnert Park office and follows a hybrid schedule: in-office Tuesday through Thursday and remote Monday and Friday. The position owns the Regulatory Affairs function and designated enterprise compliance programs within a distributed compliance model, where business functions remain accountable for executing requirements in their areas. It is not the sole owner of every enterprise compliance activity, nor is it limited to manufacturing compliance or the highly specialized regulatory model common in pharmaceuticals.
Requirements
- 7–10+ years of progressively responsible experience in Regulatory Affairs, Compliance, or related areas in regulated product environments.
- Experience exercising independent regulatory judgment and leading cross-functional initiatives.
- Experience in dietary supplements, OTC, botanical, consumer health, food/wellness, or similarly regulated CPG environments.
- Strong cross-functional leadership and project management skills, including the ability to drive initiatives without direct authority.
- Experience supporting audits, inspections, documentation systems, and compliance processes.
- Ability to operate in a growing organization with evolving processes, build systems, manage external resources, and create needed structures.
- Strong communication skills, including the ability to translate technical regulatory issues into concise business risks, options, and recommendations.
Nice To Haves
- Direct dietary supplement and/or OTC experience is strongly preferred.
- College degree (BA or BS) preferred.
- Graduate degree is a plus.
Responsibilities
- Serve as a strategic advisor to business leaders and provide risk-based regulatory guidance that accounts for requirements, commercial objectives, operational realities, consumer impact, and organizational risk tolerance.
- Partner with Innovation, Marketing, Legal, and Operations on regulatory guidance for product innovation, portfolio expansion, and commercialization.
- Assess regulatory implications, risks, and opportunities related to ingredients, claims, formulations, and market expansion.
- Develop scalable regulatory strategies for dietary supplements, OTC products, and adjacent wellness categories.
- Monitor regulatory trends, enforcement priorities, and policy developments across FDA, FTC, Health Canada/NNHPD, and related bodies, as well as relevant global frameworks.
- Support regulatory assessments and commercialization in existing and emerging international markets.
- Translate regulatory developments into business guidance, risk mitigation strategies, and operational action plans.
- Develop and recommend regulatory positions for novel, complex, or higher-risk issues and document the rationale for significant regulatory decisions.
- Develop practical paths forward when requirements are uncertain, evolving, or open to reasonable interpretation.
- Establish and maintain regulatory governance, including decision rights, responsibility matrices, escalation pathways, approval processes, regulatory calendars, and tracking of obligations and commitments.
- Assess the regulatory and compliance operating model and identify opportunities to clarify, consolidate, or transition responsibilities in partnership with Legal and functional leaders.
- Interpret and oversee compliance with requirements from government agencies, international regulatory bodies, and third-party standards organizations.
- Coordinate regulatory and compliance activities related to marketed products, manufacturing, certifications, logistics, distribution, and related business activities.
- Support regulatory reviews of claims, labeling, packaging artwork, advertising, and marketed products.
- Represent Regulatory Affairs in cross-functional governance and operating practices, and influence decisions through practical guidance and risk assessment.
- Coordinate compliance documentation, training, monitoring, and audit and inspection readiness across functions.
- Partner with Legal, Quality, Operations, HR, Marketing, and Innovation to support adherence to regulatory and certification obligations.
- Support ongoing compliance with third-party certifications, including Organic and Fair for Life.
- Coordinate certification documentation, audits, and cross-functional follow-up activities.
- Partner with internal stakeholders on responsible sourcing and manufacturing practices aligned with company standards and commitments.
- Support internal and external audit and inspection readiness, coordinate follow-up actions and documentation requests, and maintain visibility into obligations, timelines, and required actions.
- Build regulatory and compliance capabilities and operating practices appropriate for a growing business.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
