Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.
Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.
Lead advertising review process improvements and develop scalable workflows for compliance.
Review advertising and promotional claims across multiple channels for FDA, FTC, and consumer protection compliance.
Partner with Growth, Creative, and Clinical teams to streamline reviews and support timely campaign launches.
Ro is a direct-to-patient healthcare company offering nationwide telehealth, labs, and pharmacy services. It has helped millions of patients since 2017 and is recognized as a top workplace in healthcare and New York.
Serve as the Legal representative on the Promotional Review Committee and Medical Review Committee, reviewing HCP-facing, patient-facing, medical, and corporate materials for compliance with FDA regulations and industry codes.
Provide practical legal guidance across pre-launch and launch activities, including patient education, digital content, and patient support programs, balancing legal risk with business objectives.
Review non-promotional materials, evaluate claims for substantiation, and advise on compliantly navigating the regulatory landscape for digital, social, and medical affairs content.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea, and other diseases driven by dysregulated aldosterone. Headquartered in Radnor, Pennsylvania, Mineralys is a fully remote company with a collaborative, fast-moving culture.
Review advertising, website content, product pages, packaging, social media, and sales materials to ensure clinical and performance claims are accurate, substantiated, and compliant.
Evaluate supporting evidence (clinical studies, published literature, consumer research) to determine its strength for backing each claim.
Partner with Marketing, Legal, Regulatory, Clinical, and Product teams to provide clear guidance on claim wording, risk level, and additional substantiation.
Ro is a direct-to-patient healthcare company offering nationwide telehealth, labs, and pharmacy services. Since 2017, Ro has helped millions of patients and is recognized as a top workplace in Health Care, earning multiple honors from Fortune and Great Place to Work.
Coordinate end-to-end review and approval of promotional, advertising, and commercial materials in a regulated life sciences environment.
Serve as central point of contact for internal teams and external partners, managing documentation, timelines, and approval records.
Work closely with Regulatory Affairs, Legal, Medical, Compliance, Marketing, and Commercial stakeholders to ensure efficient and compliant reviews.
A growing life sciences organization dedicated to advancing regenerative medicine through innovative products and high-quality solutions. The company fosters a collaborative culture focused on accountability, adaptability, continuous learning, and customer-centric innovation.