THE ROLE: REGULATORY AFFAIRS MANAGER You 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 REQUIRED
- Bachelor'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.
WHAT TO EXPECT DURING THE INTERVIEW PROCESS
- Initial video screen with a member of our Talent team
- Round 1: Conversation with the Hiring Manager + 1-2 conversations with other Ollies on the team
- Round 2: 2-3 conversations with team or cross functional Ollies
- Final Round: Homework*
*At OLLY, our final round is called Homework. Candidates who participate in this round are given 3 questions in advance to answer and present to the interview panel they previously spoke with in the process. We understand every candidate is different. If you need a reasonable accommodation to adjust this procedure, please let us know as soon as possible so that we can evaluate and provide other options that work for your needs THE DETAILS LOCATION: San Francisco or Los Angeles, CA HOURS: Full-time, Exempt MANAGER: Regulatory Affairs Director PLEASE 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 location WHAT WE OFFER:
- An opportunity to work with an intelligent, inspiring, and extraordinarily fun team
- 100% employer-paid medical coverage for employee only, dental + ortho, and vision insurance
- 4 weeks PTO + paid holidays + 12 Mental Health Days per year
- 100% Paid parental leave, Fertility + Adoption Benefits
- Annual Bonus
- 401(k) plan with Employer Match
- Hybrid Work + Wellness + Cell Phone Stipends
- Free product
- And much more!