Regulatory Specialist, Consumer Health Products
About Ro
Founded in 2017, Ro is a patient-driven telehealth company that puts you in control of your health. We’re patients, just like you, building technology to make healthcare accessible, affordable, and maybe even enjoyable. Ro powers three digital health clinics -- Roman for men’s health, Rory for women’s health, and Zero for fighting smoking addiction -- as well as Ro Pharmacy, a simple and affordable online pharmacy where every medication is $5 per month. The company’s nationwide networking of physicians and pharmacies provides a personalized, end-to-end healthcare experience from online treatment to the delivery of medication and ongoing care. Ro was named #2 in Wellness on Fast Company’s 2019 list of the World’s Most Innovative Companies, listed by Inc. Magazine as a Best Place to Work in 2020, and earned its Great Place to Work Certification in 2020.
We’re looking for a Regulatory Specialist, Consumer Products, to join the growing legal team at our headquarters in New York! This role will report to our Director of Regulatory Affairs and will manage all things related to ensuring our ingredients, labels, and marketing claims are compliant with applicable regulations and guidelines.
Who are you? You are an individual who is comfortable working within a new and evolving industry while handling several projects at the same time. You will have a major impact on Ro’s plans to scale and will work with each department at the company. You are, friendly, flexible, and eager to learn about all facets of the business.
What You’ll Do:
- Be the first-line-of defense in reviewing a wide variety of content within Ro’s unique medical-legal-marketing review process. This content includes: Facebook and Google ads, website pages, national TV spots, podcast reads, and out of home billboards
- Foster a close partnership between the legal, medical, marketing, growth, and physical product teams.
- Learn Ro’s business through and through to enable a multi-dimensional review of content.
- Work closely and cross-functionally with other teams to support new strategic initiatives.
- Develop and routinely update SOPs and working instructions to facilitate a consistently high performing and efficient review processes.
- Assist new Physical Product Development team with formula validation, claim substantiation, and labeling.
- Partner with Physical Product Development, Marketing, and Creative to review product labels, artwork design, and advertising.
- Provide input on the acceptability of product claims, advertising copy, and other marketing material for technical accuracy and regulatory compliance.
- Coordinate with contract manufacturers and internal teams to gather raw material documentation and analyze its validity.
- Participate in CMO audits, as necessary, including preparation of audit plans and documentation of post-audit findings.
- Facilitate regulatory submissions such as claims submissions and registration of new products.
- Responsible for keeping up with and understanding the regulatory environment and interpretation of regulations for dietary supplements, personal care products, and OTC medications.
What You’ll Bring:
- Bachelor's degree (BA or BS) required.
- 2-5 years of FDA-regulated product industry experience, including 2-4 years in regulatory affairs.
- Knowledge of the regulatory landscape for the labeling and manufacturing of various FDA regulated products including dietary supplements, OTC monograph drugs, and personal care products.
- Familiarity with FDA advertising and promotional regulations and guidance.
- Must be able to innovate, analyze, and solve problems with minimal supervisory input.
- Excellent communications, listening, and negotiation skills are necessary.
- Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
- Must have outstanding attention to details.
Bonus Points:
- Post-graduate degree in a scientific discipline
- Familiarity with healthcare laws and regulations
- Familiarity with digital and direct-to-consumer advertising
Benefits + Perks
• Full medical, dental, and vision insurance + OneMedical membership
• Healthcare and Dependent Care FSA
• Commuter benefits
• 401(k)
• Unlimited PTO
• Fitness reimbursement
• Paid maternity/parental leave
• A never-ending supply of office snacks + coffee
• The cutest office dog you’ve ever seen
We welcome qualified candidates of all races, creeds, genders, and sexuality to apply.
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