• Lead all regulatory activities related to medical and promotional material development, review, and external communications for Mineralys as it advances toward commercialization. • Serve as the primary regulatory representative on the Medical, Legal and Regulatory (MLR) team, ensuring that all promotional, non-promotional and scientific exchange materials adhere to internal policies, relevant laws, FDA regulations, and industry standards. • Provide timely, compliant strategic guidance for all promotional and non-promotional materials development. • Interpret and apply FDA Advertising & Promotion regulations, guidance, OPDP expectations and enforcement trends, to company materials. • Serve as a strategic thought partner with Marketing and Medical Affairs to develop compliant and compelling promotional and medical strategy and framework ahead of launch. • Collaborate cross-functionally with Medical Affairs, Commercial, Legal, Clinical Development, and agency partners on messaging and claims substantiation. • Provide regulatory guidance on digital and omnichannel content, including modular content, rapid update scenarios, and social media platforms. • Review all relevant materials, including but not limited to digital and print assets, HCP and patient-facing materials, disease awareness, sales training, company-controlled medical education, press releases, social media, and investor communications (as appropriate) to ensure compliance. • Partner with Marketing Operations to ensure seamless MLR execution, workflow design, SOPs, timelines, and cross-functional coordination. • Lead interactions with OPDP, including advisory comments, submissions, and correspondence. • Orchestrate promotional audits and monitoring, and corrective actions as appropriate. • Monitor and interpret regulatory developments related to Advertising & Promotion and proactively update the organization regarding implications. • Support internal training on Advertising & Promotion requirements. • Build strong relationships across Medical, Legal, Commercial, Clinical, and Compliance functions, providing balanced solutions-oriented guidance. • Facilitate discussions around regulatory risk tolerance and best practices to enable compliant and competitive brand execution.