Senior Manager Regulatory Affairs chez East West Tea

Title of Role: Senior Manager Regulatory Affairs

Department: Quality

East West Tea is seeking a talented, passionate, and experienced Senior Manager Regulatory Affairs to join our Quality team! 

The Senior Manager Regulatory Affairs will review product formulations, labels, claims substantiations, develop Yogi’s regulatory framework, and support cross-functional teams with expert regulatory guidance. Working with external legal counsel to ensure compliance and maximize commercial effectiveness. Utilizing knowledge of the Regulatory and Legal environment in USA and Canada (21 CFR part 101, 111, 7 CFR Part 205 and Natural Health Products Regulations) to ensure our products are compliant within a changing market as we maintain our portfolio and innovate in hot tea, concentrates and other new categories. Your ability to think strategically, create solutions and communicate effectively to diverse teams will be key to success in this role. 

WHO WE ARE:

We are the well-being company that exists to inspire and enhance everyday life through trust and good will.  Our guiding principles, beliefs, and philosophies shape our identity. They are the essence of our culture and define how we do what we do.

We are Intentional – we chose to lead with positive intent. Mindful – we are present and aware of how we show up in the world.  People – we value and respect all people and communities.  Authentic – we are real and transparent with everything we do.   Committed – we are committed to quality products while sustaining our planet.  Trust – we consistently align our words with our actions.  

OUR INVESTMENT IN YOU:

• We have exceptional wellbeing-focused benefits including health, dental, vision and alternative care, life and disability insurance, retirement, paid time off, company picnics, social activities, and a surprise every so often!  Who doesn’t love a surprise? 
• This position is located in Eugene, Oregon.
• As a certified B Corp, we’re a company that lives our values every day.
• We work in a LEED certified facility which prioritizes the planet in our daily operations and optimizes our employee experience while at work. 
• We prioritize sustainability as a business by embedding it into our values, our strategic priorities, our decision-making, and our resource allocations.
• Our Nourish Market provides employees subsidized healthy lunch and snack options.
• We commit to our purpose in every aspect of our culture. 
• We have employees that are committed to “Doing Good” in our community and around the world.
• We are a growing company with products that customers love. 
• We believe in investing in you and your growth and development. 

WHAT YOU’LL OWN:                               

Content Review and Compliance                                                                                            50% of time

• Review and approve product formulations, labels, and claims for compliance with 21 CFR 101, 21 CFR 111, USP 561, 7 CFR Part 205, US FDA/DSHEA and other applicable regulations and have a working knowledge of international regulations (e.g., NHP SOR/2003-196)
• Create, lead and collaborate on claims substantiation process to ensure ingredient usage, nutritional limits and health claims are aligned with country-specific regulatory requirements
• Lead cross functional teams through optimization of label/content review processes to assess potential impact on the company’s product portfolio and advise on risk mitigation strategies
• Oversee regulatory monitoring and horizon activities- review and analyze the new and emerging regulations and trends from government agencies that affect the company
• Ensure that information concerning such regulations and requirements, especially new or modified, is distributed to appropriate decision makers

Strategic Responsibilities                                                                                                         20% of time

• Support to Brand, R&D for innovation and Renovation Product Development including ingredient status, permissible limits, and labeling requirements to ensure product concepts are regulatory-compliant from the early stages of development
• Track and analyze draft regulations, standards, and global regulatory trends
• Lead relationship management on behalf of the company with appropriate regulatory agencies (FDA, QAI, Health Canada) and customers (for regulatory matters) ensuring strong collaborative partnerships

Operational Responsibilities                                                                                                   30% of time

• Key relationship manager for external certifying partners
• Develop, monitor, and report on Key Deliverables in regulatory affairs (e.g., adverse events and significant adverse events)
• Provide leadership as an engaged business partner between key stakeholders (QA, R&D, Sales, Marketing, Consumer Affairs, Operations) to ensure questions and questionnaires and other communications are completed to ensure speed to market

WHAT YOU KNOW AND HAVE EXPERIENCED: 

• Bachelor's or Masters in Science, Food Science, Nutrition, or related field
• 10+ years of experience in regulatory affairs within food and supplements (experience in both required) in FMCG/CPG
• Strong understanding of applicable US regulations (not limited to 21 CFR 111, USP 561, 7 CFR Part 205, US FDA/DSHEA, Prop 65 and AB 347 in California)
• Professional experience with claims substantiations in supplements and food
• Experience in handling product registrations and compliance for Health Canada preferred

YOU’LL BE A GREAT FIT:

• Strong critical thinking ability to navigate and solve complex problems
• Solid work ethic, self-starter, and result-oriented
• Natural ability to develop strong, trusting relationships
• Enjoys collaborating with cross-functional partners
• Responsible and a high degree of ownership
• Thrives in an ever-changing work environment
• Effectively managing a multitude of work responsibilities
• Balances attention to detail and swift execution