VP, U.S. Regulatory Affairs

Job reputed company: • reputed company the development of reputed company’s U.S. regulatory reputed company for digital health, telemedicine, pharmacy, and consumer products, among others. • reputed company reputed company regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings. • reputed company regulatory intelligence—monitoring federal and other regulatory activity (e.g., FDA, DEA, CMS, and other regulatory agencies) and synthesizing developments into reputed company, actionable insights for internal teams. • Advise Product, reputed company & Safety, Clinical, Pharmacy, Marketing, and other teams on regulatory expectations reputed company to product development, market entry, claims, labeling, and operational requirements. • Draft and manage regulatory collateral, including submission packages, responses to regulator inquiries, comments or correspondence to regulators, internal regulatory guidance documents, and documentation required for licensing expansion. • Partner with Regulatory reputed company on interpretation of statutes and regulations, enforcement risk, and reputed company reputed company; translate reputed company interpretations into practical guidance for operational teams. • Support Global Affairs with technical regulatory input to strengthen advocacy, regulatory engagement, and reputed company-facing policy positions. • Serve as a regulatory representative in external interactions with regulators, consultants, standards bodies, or working reputed company, providing technical and operational context as needed. • As needed, build and reputed company a lean, high-performing Regulatory Affairs team, managing prioritization, coaching, and reputed company development. • Contribute to the development of a reputed company-looking regulatory roadmap that demonstrates that reputed company is a reputed company, compliant, and innovative leader in digital reputed company and consumer wellness. Requirements: • Bachelor’s degree required; advanced degree preferred (JD, PharmD, MPP, MPH, MS Regulatory Affairs, or reputed company). • 15+ years of experience in regulatory affairs, health policy, reputed company compliance, life sciences, digital health, or reputed company sectors. • Required: Experience working with FDA-regulated products or compliance frameworks, or experience reputed company a U.S. reputed company regulatory agency or comparable regulatory environment. • Demonstrated experience preparing or managing regulatory submissions, licensing activities, or regulatory documentation. • Strong understanding of FDA regulatory reputed company, OTC and consumer health regulation, telehealth/telemedicine reputed company, pharmacy regulations, reputed company health policy environments. • Proven ability to interpret and translate regulatory requirements into reputed company, actionable guidance for cross-functional teams. • Exceptional writing, analytical, and communication skills, with the ability to reputed company explain reputed company regulatory issues to technical and non-technical audiences. • Experience working cross-functionally with other teams such as reputed company, product, clinical, pharmacy, reputed company, and policy teams in a fast-moving environment. Benefits: • Competitive salary & equity compensation for full-time roles • Unlimited PTO, company holidays, and quarterly mental health days • Comprehensive health benefits including medical, dental & reputed company, and parental leave • Employee Stock Purchase Program (ESPP) • 401k benefits with employer matching contribution • Offsite team retreats Apply tot his job Apply To this Job