Hims and Hers is a health and wellness brand built to make healthcare accessible for all, regardless of gender, insurance status, or location. Since launching in November 2017, we’ve raised over $200MM in funding and are one of the fastest growing direct-to-consumer brands in history. Our mission is to make it easier for people to gain access to medicines they need, such as birth control, hair loss treatments, prescription skin care, and even low libido solutions.
The regulatory manager will be responsible for keeping us in-line with all regulatory bodies for our cosmetic, OTC and Rx products. They will sit on the product team, but work with marketing, legal, creative, operations, and third party manufacturers to ensure that we are always safe and fair to consumers, while upholding our marketing standards. The regulatory manager will also be responsible for coordinating and carrying out claims testing in conjunction with operations and product. The primary work will be related to US regulatory work, but there will be potential for expanded responsibilities as we look towards international opportunities.
- Own compliance for all copy. Review copy primarily for FDA/FTC compliance based on product category, completed claims testing, and research-based substantiation. Keep us technically accurate and 100% compliant while still maintaining competitive marketing that meets consumer expectations.
- Own claims testing plans and execution for all product categories. Work with product dev to review product briefs and clarify goals/objectives. Outline where claims testing is necessary. Provide testing briefs to product and production with timelines and costs. Source testing labs, coordinate arrival of bulk samples and components, and provide details and interpretations of results to all stakeholders alongside recommendations.
- Own regulatory testing plans for all products in stability and safety. Testing must not just comply with product regulations in our marketed countries but also hold us to a high standard of product quality and safety for our end-users. Outline various testing plans and timelines, coordinate the details of the testing.
- Review all packaging, advertising (digital and physical) and internal/external training materials for technical accuracy and compliance--from the large strokes of the claims, to the details of the ingredient lists; raising flags, finding solutions, and providing input as needed.
- Work on international regulatory compliance with domestic and foreign agencies
- Coordinate with operations on any production QA issues
- Manage all label artwork creation and updates, working with the design and legal teams
- Ensure that all product labels are labeled properly and meet FDA standards, as well as the standards of any other country we may sell in
- Create or consult on nutritional and ingredient statements for all products
- Stay up-to-date on regulatory changes to ensure we remain in compliance
- Ask for support as needed when facing new challenges
- Degree in a scientific discipline, MS or PhD preferred
- Multiple combined years of experience in cosmetics, OTC, and prescription regulatory, emphasis on cosmetics and OTC
- 5+ years of regulatory experience
- Top-notch communication skills and management expertise
To apply, please send a resume and a little blurb about your badass self to firstname.lastname@example.org