Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
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.
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.
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.
Review all customer-facing marketing materials to ensure compliance with legal and regulatory guidelines.
Serve as a partner to cross-functional teams, providing guidance on compliant messaging and exercising judgment on escalations.
Lead documentation of best practices and develop an intake system for marketing review requests.
Hims & Hers is a leading health and wellness platform on a mission to help people feel great through better health. As a public company traded on NYSE (HIMS), they prioritize customer-first personalized care and offer a talent-first remote work culture.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Review and edit promotional content for grammar, style, and regulatory compliance.
Fact-check and proofread existing content for consistency across channels and audiences.
Partner with project managers, designers, and writers to manage multiple projects.
P10 is a creative agency that challenges traditional agency norms and embraces change to improve how things work. It brings together a diverse, remote-only team of seasoned professionals to deliver exceptional value for clients.
Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.
The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.
Oversee regulatory labeling activities throughout the product lifecycle, from initial assessments to post-approval updates.
Evaluate regulatory changes, coordinate product information revisions, and prepare Health Authority submissions.
Collaborate with cross-functional teams to maintain compliance with evolving regulatory requirements.
A global clinical research organization dedicated to improving patient outcomes through regulatory affairs and medicinal product compliance. It fosters a collaborative, patient-focused culture with opportunities for professional development.
Oversee delegated audits related to UM, Credentialing, Claims, Enrollment, and Appeals processes to ensure compliance with payer contracts.
Educate staff, update policies and workflows, and act as a liaison between payers and local market leadership during audits.
Operationalize regulatory communications from governing bodies and document process changes for upstream and downstream teams.
Dignity Health Management Services offers integrated management and business services to healthcare providers, focusing on managed care administrative and clinical services to contain costs and improve quality. It is part of CommonSpirit Health, a large health system with a mission-driven culture centered on community and patient care.