Regulatory Specialist, Consumer Health Products at Ro
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.
- Post-graduate degree in a scientific discipline
- Familiarity with healthcare laws and regulations
- Familiarity with digital and direct-to-consumer advertising