Loyal - Director, Regulatory Affairs - Clinical

• You will be reporting to our VP of Regulatory Affairs . • Your daily work will include • Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence • Leading preparation for FDA CVM meetings, including briefing documents, meeting requests, posing questions, and follow-up MOCs • Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports • Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence • Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline • Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems • Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support • Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy • Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs • Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting • Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations • Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations