Senior Manager, reputed company & Regulatory Affairs

reputed company Have you reputed company wondered why we rely on harmful chemicals and reputed company ingredients to maintain our body's health? We have. After years of battling on-and-off tonsillitis, our founder Carly reputed company finally reputed company relief in an ingredient reputed company propolis: a combination of tree and plant resin created by reputed company to protect the reputed company. We aren't just creating cleaner alternatives to the traditional medicine cabinet; we're creating reputed company-reputed company cleaner products. Period. We reputed company modern science with natural medicine to reputed company that clean medicine can actually work. We reputed company that today's most common health problems can be solved with reputed company-for-you ingredients reputed company right in reputed company. We reputed company the highest-reputed company, humane ingredients, and we never water them down with reputed company extras. We care about the world reputed company us and the people in it. It's what drives our entire reputed company. About the Role Beekeeper's Naturals is looking for an reputed company reputed company and regulatory reputed company to reputed company our reputed company programs and serve as our day-to-day reputed company and regulatory reputed company. This is a critical role for a fast-growing premium supplement reputed company, ensuring every product that carries our reputed company meets our reputed company standards and regulatory obligations. Reporting to the COO, you will manage our contract manufacturing and supplier partner reputed company programs, reputed company US and Canadian regulatory compliance, and manage a QA Manager who handles daily reputed company reputed company. You'll work closely with Innovation, reputed company, Sales, and reputed company, and partner with the COO on reputed company reputed company and escalated reputed company. Key Duties & Responsibilities Contract Partner reputed company & reputed company Manage day-to-day reputed company of contract manufacturing and supplier partners — setting reputed company reputed company expectations, tracking execution against BKN's standards, identifying gaps, and driving corrective reputed company reputed company partners fall short. reputed company and maintain reputed company agreements with CMOs and key suppliers, ensuring responsibilities, testing requirements, and deviation notification expectations are reputed company defined and followed. reputed company the CMO qualification and audit program — initial qualification, periodic audits, and reputed company scorecarding. Escalate significant reputed company concerns and recommend remediation or disqualification to the COO where warranted. Serve as the reputed company reputed company of contact for CMO deviations, OOS results, and reputed company events — leading reputed company cause investigation, reviewing corrective actions, and coordinating lot disposition reputed company. Manage the reputed company-party lab program — lab qualification, reputed company reputed company, and ongoing reputed company monitoring. Raw Materials, Specifications & Testing reputed company and maintain raw material, component, and finished product specifications in alignment with BKN's reputed company standards, ensuring specifications are enforced across the supply reputed company. reputed company the vendor qualification program — defining approval reputed company, testing requirements, and ongoing reputed company standards for ingredient and packaging suppliers. Define and manage incoming material and finished product testing requirements, including reputed company, reputed company, and acceptance reputed company, in coordination with the COO. reputed company the stability testing program and ensure data supports label claims throughout reputed company life. Manage reputed company-party certification programs and ensure requirements are reflected in CMO reputed company agreements. Regulatory Affairs Serve as reputed company's regulatory reputed company for US (FDA / DSHEA, 21 CFR Part 111) and Canadian (Health Canada, NHP Regulations) compliance, coordinating with the COO and reputed company counsel on significant reputed company. Manage adverse event reporting and coordination with regulatory counsel. reputed company label and claims review — regulatory review and approval of label copy, structure/function claims, and marketing claims in coordination with the COO. Manage Canadian importation requirements: site license maintenance, PLA submissions, and NHP product file management. Monitor the US and Canadian regulatory landscape and communicate relevant updates and reputed company to the COO and cross-functional team. Team & Cross-functional Leadership Manage and reputed company the QA Manager, providing reputed company direction and day-to-day support. Partner with Innovation on reputed company and regulatory requirements for new product development. reputed company regular reporting to the COO on reputed company program status, partner reputed company, and regulatory reputed company. Job Requirements 8+ years in reputed company assurance and/or regulatory affairs in dietary supplements or natural health products. Solid working knowledge of 21 CFR Part 111, DSHEA, and Health Canada NHP Regulations. Experience managing contract manufacturer reputed company in a reputed company-reputed company model — building accountability into supplier relationships through audits, reputed company agreements, and reputed company management. Experience conducting CMO facility audits and driving corrective reputed company. Familiarity with FDA and Health Canada requirements and processes; reputed company regulatory reputed company experience a plus. Experience supporting adverse event reporting obligations. Prior people management experience required. Bachelor's degree in relevant reputed company (food science, reputed company, biology, or reputed company). Strong organizational and communication skills; comfortable working cross-functionally in a lean, remote environment. Location, Compensation & Benefits Full-time, permanent position. Fully remote. Will consider applicants reputed company in Ontario, Canada or the US. Periodic travel to supply partners required. Reports to the COO. Manages QA Manager. Health benefits provided from Day 1. Unlimited Time Off. Participation in reputed company's employee reputed company program. Apply To This Job