Director, Regulatory Strategy at Tarsus Pharmaceuticals in Irvine, CA

Job description

About the Role The Director, Regulatory Strategy will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The individual will function as the regulatory lead for their assigned projects. Experience in development and clinical regulatory activities and providing regulatory leadership on the project teams in this area is required. The candidate will also directly provide or oversee pre- and post-approval submissions activities. The candidate should have a good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. A high attention to detail, ability to coordinate and prioritize assigned activities according to project goals and strong interpersonal skills, both written and verbal, are desired. The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, PhD or PharmD). Key responsibilities of the role: Provide regulatory leadership on the project teams, with a focus on development and clinical regulatory affairs, but with good knowledge of other areas of regulatory affairs. Work with project teams to resolve complex project issues utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements. Work in close collaboration with other functional leads to plan, prioritize, supervise and/or conduct project activities. Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Develop regulatory strategic plans, either directly or in conjunction with project teams. Lead or oversee the preparation of regulatory submissions for assigned projects; responsible for quality and timeliness of IND/CTA/NDA/MAA and post-approval submissions. Work with cross-functional partners and contractors in the preparation, review, and completion of documents for regulatory submissions. Provide strategic leadership and development to other regulatory strategists to ensure innovative, robust, fit-for-phase regulatory strategies for from FIH to approval. Provide regulatory strategy leadership for business development and due diligence, including assessment of asset, risk identification and mitigation, precedent leverage, regulatory probability of success Establish best practices across Regulatory Affairs and other R&D functions to ensure consistent, high-quality execution Follow company policies and procedures for regulatory record keeping and lead development of new regulatory policies and procedures. Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Factors for Success: The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, Ph.D. or Pharm D.). Excellent verbal and written communication skills. Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project teams. Ability to thrive in a fast-paced, entrepreneurial environment. Ability to function at a high level in a team setting or acting as an individual contributor. An excellent understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. A high attention to detail and ability to coordinate and prioritize assigned projects. Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions. Collaboration and Team Building - Builds strong relationships and networks. Is curious about and r