Regulatory Affairs Manager San Francisco, CA
: Job Details :


Regulatory Affairs Manager San Francisco, CA

TBWA\Chiat\Day

Location: Oklahoma City,OK, USA

Date: 2024-11-15T08:02:28Z

Job Description:

WE'RE HERE TO BRING DELIGHT TO THE WORLD OF NUTRITIONOLLY is a fast-growing company working to bring simplicity and delight to the world of nutrition. Yes, stuff like vitamins and probiotics. We see only upside in the opportunity to transform the category experience. Not only that, we believe you can't have happy without healthy. And isn't true happiness where it's at? So we've made it our personal mission to help people make healthy choices by making it easier than ever for them to get better nutrition into their daily lives. We're super passionate about the work that we do and we're on the hunt for a fellow self-starter to join our ambitious bunch.We hope you'll indulge us as we toot our own horn a little. We currently have over 40 products sold nationwide at retailers including Target, CVS, Safeway, Whole Foods, Walmart and many more. We got off to a fast start and have already been recognized as a successful, transformational brand in both the supplement and nutrition categories. As you can imagine we need more rock stars to help us continue the pace as we have high hopes for our future.OK, one last tidbit or two - in 2019 we joined our friends over at Unilever to help us grow OLLY into a global brand. We are also a B-Corp, so doing social good is built into our DNA and we're headquartered in the heart of San Francisco with a culture that reflects the friendly, optimistic and health-minded values of the brand. Our goal is to build a uniquely special company and brand that will make us all proud!BUT ENOUGH ABOUT US LET'S TALK ABOUT YOUYou are welcome at OLLY for who you are, no matter where you come from, what you look like, or what healthy means to you. Our products are for everyone, and so is our workplace. The more voices we have represented and amplified in our business, the more we will all thrive, contribute, and shine. So bring us your personal experience, your perspectives, and your background. It's in our differences that we will find our inspiration to help people be happy from the inside out.THE ROLE: REGULATORY AFFAIRS MANAGERYou are a compliance expert with roots in the supplement industry and have a passion for supporting the innovation of uniquely effective dietary supplements. You have extensive knowledge of the regulatory requirements to make substantiated label and marketing claims. You are detail- and solution-oriented, communicate effectively, and are a collaboration ninja.You will be responsible for leading daily end-to-end regulatory support to create, grow, and protect the OLLY business. This role will partner with Product Development, Quality, Sales, Brand, Marketing, and Creative teams to provide regulatory guidance for labeling, formula compliance, advertising, and marketing of OLLY products. The RA Manager will serve as the company's operational expert on claims substantiation, providing direction and insights to appropriate internal stakeholders on the creation and maintenance of claims with regards to existing, new, and emerging regulations as well as enforcement initiatives. This expertise will enable OLLY to continue to grow as a competitive and agile business, enabling speed to market with competitive and compliant product claims. The RA Manager reports directly to the RA Director.KEY RESPONSIBILITIES:Collaborate cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA and FTC regulations.Use risk management principles and deep regulatory insight to solve problems and identify compliant solutions as a proactive business partner throughout the product's lifecycle.Develop and maintain regulatory substantiation files, ensuring adequate substantiation for product and ingredient claims and compliance with all regulatory agencies to protect the brand while driving growth.Ensure consistent and compliant use of claim language across all marketing materials, including label copy, web content, and marketing collateral.Develop label specifications, Nutrition/Supplement Fact Panels, and ingredient/allergen statements in compliance with applicable regulations.Oversee the review and approval of labels, supplement facts panels, formulas, and ingredients for regulatory compliance.Support the Olly Innovation pipeline.Keep current with developing laws, regulations, and enforcement activities impacting the use of ingredients, product safety, labeling, and advertising to provide effective regulatory assessment and impact of proposed changes to the business.Manage and track all regulatory submissions, including FDA 30-day notices for structure/function claims, product information/labels in Supplement OWL, and others as needed.Develop, implement, and revise SOPs, Work Instructions, and forms as needed, as they pertain to the Regulatory Affairs operations to ensure consistency and compliance.CAPABILITIES + SKILLS REQUIREDBachelor's degree in Regulatory Affairs, Biological, Health, Nutrition Sciences, or a related field is required.5-7 years of regulatory affairs experience in an FDA-regulated industry is required, with dietary supplement experience strongly preferred.Extensive knowledge of FDA, FTC, and USDA's regulatory requirements and compliance in dietary supplements and foods is required.Experience in conducting label and marketing reviews, developing claim substantiation, and supporting innovation is required.Experience with dietary supplement GMPs (21 CFR 111) is required.Demonstrated leadership skills in driving results, collaboration, and communication across departments are required.Ability to collaborate cross-functionally and establish true partnerships, particularly with Marketing, Product Development, and Contract Manufacturers, is required.Excellent verbal and written communication skills, including analysis, interpretation, and reasoning, are required.Highly organized with critical attention to detail, including the ability to handle multiple tasks, meet deadlines, and prioritize assignments, all while maintaining a focus on internal and external customer service, is required.Solution-oriented and able to work in a fast-paced environment with changing priorities is required.Experience with foreign regulatory agencies and international regulations is a plus.Consistently demonstrates a professional, positive, collaborative, and approachable attitude and demeanor.General project management skills and knowledge of the product development process are a plus.Willingness to travel as required.Demonstrated ability to handle confidential and sensitive information with discretion.THE DETAILSHOURS: Full-time, ExemptMANAGER: Regulatory Affairs DirectorPLEASE NOTE: Candidates must be authorized to work in the United States without sponsorship.The pay range for this position is $125,000 - 150,000 dependent on locationWHAT WE OFFER:An opportunity to work with an intelligent, inspiring, and extraordinarily fun team100% employer-paid medical coverage for employee only, dental + ortho, and vision insurance4 weeks PTO + paid holidays + 12 Mental Health Days per year100% Paid parental leave, Fertility + Adoption BenefitsAnnual Bonus401(k) plan with Employer MatchHybrid Work + Wellness + Cell Phone StipendsFree productAnd much more!#J-18808-Ljbffr

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