Senior Manager, Regulatory Affairs and Compliance
hace 4 días
Rohnert Park
Job DescriptionThe Senior Manager, Regulatory Affairs & Compliance, is a cross-functional role responsible for helping Traditional Medicinals scale responsibly within an increasingly complex regulatory, certification, and compliance environment. The role serves as the functional leader for Regulatory Affairs and Compliance at the Company, with responsibility for establishing regulatory strategy, providing authoritative regulatory guidance, and building and operating the systems, governance, and capabilities necessary to support the Company’s growth. The role will also assume ownership of selected compliance responsibilities that are currently distributed across the organization as the Company continues to mature its compliance operating model. The ideal candidate is equally comfortable interpreting regulatory requirements, coordinating cross-functional compliance activities, supporting audit/inspection readiness, and building scalable processes that reduce reliance on fragmented/manual coordination. Reporting to the Associate General Counsel, this role partners closely with Quality, Operations, Human Resources, Marketing, and Innovation to ensure the Company continues to operate responsibly and compliantly as the business, manufacturing footprint, and regulatory environment evolve. This position follows a hybrid work schedule based out of our Rohnert Park office. Employees are expected to work in-office Tuesday through Thursday, with Monday and Friday designated as remote workdays. Key ResponsibilitiesRegulatory Business Partnership • Serve as a trusted strategic advisor to business leaders, providing risk-based regulatory guidance that considers regulatory requirements alongside commercial objectives, operational realities, consumer impact, and organizational risk tolerance., • Partner with Innovation, Marketing, Legal, and Operations to provide proactive regulatory guidance supporting product innovation, portfolio expansion, and commercialization initiatives., • Assess regulatory implications, risks and opportunities associated with new ingredients, claims, formulations, and market expansion activities., • Support development of scalable regulatory strategies for dietary supplements, OTC products and adjacent wellness categories., • Monitor and analyze emerging regulatory trends, enforcement priorities, and policy developments across FDA, FTC, Health Canada/NNHPD and related regulatory bodies., • Support regulatory assessments and commercialization activities for existing and emerging international markets., • Maintain awareness of evolving global regulatory frameworks relevant to dietary supplements, OTC products, botanicals and wellness products., • Translate evolving regulatory developments into practice business guidance, risk mitigation strategies, and operations action plans., • Develop and recommend regulatory positions and strategies for novel, complex, or higher-risk issues, including documenting the rationale for significant regulatory decisions., • Develop practical paths forward where regulatory requirements are uncertain, evolving, or subject to reasonable interpretation rather than defaulting solely to the most conservative regulatory position., • Establish and maintain a scalable regulatory governance framework, including clear decision rights, responsibility matrices, escalation pathways, approval processes, regulatory calendars, and mechanisms for tracking regulatory obligations and commitments., • Assess the Company's evolving regulatory and compliance operating model and, in partnership with Legal and functional leadership, identify opportunities to clarify, consolidate, or transition regulatory and compliance responsibilities currently distributed across the organization.Regulatory Affairs & Compliance Coordination, • Interpret and oversee compliance with current requirements established by government agencies, international regulatory bodies, and third-party standards organizations., • Coordinate regulatory and compliance activities associated with marketed products, manufacturing, certifications, logistics/distribution, and related business activities., • Support regulatory review activities related to claims, labeling, packaging artwork, advertising, and marketed products., • Monitor regulatory developments and translate new or updated requirements into practical business actions and compliance plans.Cross-Functional Compliance Management, • Serve as key regulatory leader and advisor across cross functional initiatives, • Represent regulatory Affairs in cross functional governance processes and operating practices aligned with organizational growth., • Influence cross-functional decision making by providing clear, practical regulatory guidance and risk assessment., • Coordinate compliance-related documentation, training, monitoring, and audit/inspection readiness activities across functions., • Partner with Legal, Quality, Operations, HR, Marketing and Innovation to support adherence to regulatory and certification obligations., • Establish scalable regulatory governance processes and operating practices aligned with organizational growth.Certifications & External Standards, • Support ongoing compliance with third-party certification requirements, including Organic and Fair for Life., • Coordinate certification-related documentation, audits, and cross-functional follow-up activities., • Partner with internal stakeholders to support responsible sourcing and manufacturing practices aligned with Company standards and commitments.Audit & Inspection Readiness, • Support internal and external audit/inspection readiness activities., • Coordinate follow-up actions, documentation requests, and cross-functional preparation efforts., • Establish and maintain visibility into compliance obligations, timelines, and required actions.What This Role Is (and Is Not)This role is:, • A broad, enterprise-focused regulatory leadership role requiring strategic judgment, initiative, and cross-functional ownership., • The functional leader and primary internal authority for Regulatory Affairs., • The owner of the Company’s regulatory strategy, operating model, governance, processes, and regulatory capability development., • A strategic advisor to senior leaders and cross-functional teams on regulatory risk, opportunities, and business decisions., • A builder of scalable regulatory and compliance capabilities appropriate for a growing consumer health business., • A leader who identifies regulatory and compliance responsibilities that should be centralized, clarified, or transitioned as the organization evolves.This role is not:, • The sole owner of all compliance activities across the enterprise. The role owns the Regulatory Affairs function and designated enterprise compliance programs but operates through a distributed compliance model in which business functions remain accountable for executing requirements within their areas of responsibility., • An intra-functional compliance role (e.g. Manufacturing-only compliance)., • Analogous to the type of highly-specialized Regulatory Affairs functions commonly found in more heavily regulated industries (e.g. pharmaceuticals).Requirements, • 7–10+ years of progressively responsible experience in Regulatory Affairs, Compliance, or related areas, in regulated product environments, including 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; direct dietary supplement and/or OTC experience strongly preferred., • 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., • Comfort operating in a growing organization where processes are evolving, including the ability to build systems, manage external resources, and create structures where needed., • Strong communication skills, including the ability to translate technical regulatory issues into concise business risks, options, and recommendations. Education: • College degree (BA or BS) preferred., • Graduate degree a plus.Why This Role MattersAs Traditional Medicinals grows its manufacturing footprint, product portfolio, certifications, and operational complexity, the Company’s regulatory and compliance coordination needs are increasing significantly. This role will strengthen scalable regulatory and compliance capabilities, support responsible growth, and preserve leadership capacity for higher-order strategic, governance, and legal work. Salary Range for this position is : $ 155,900.00 - $204,645.00 Physical/Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Traditional Medicinals, Inc. and its subsidiaries are proud equal-opportunity employers. We wholeheartedly embrace authenticity, diversity, and people's differences. We acknowledge, celebrate, and support individuality to the great advantage of our consumers, our stakeholders, our products, and the planet. We are committed to building an inclusive workplace for all our people. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. Powered by JazzHR TdYoX4VbGl
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