Director, Regulatory & Clinical Strategy

Position: The Director will direct, manage, and implement regulatory projects in support of company goals across clinical strategy areas. The position plays a major role in shaping a cohesive regulatory strategy across assigned programs and ensuring the effective integration of broad regulatory ideas and tactics into program and platform strategy. Responsibilities may be global, regional, or local, depending on program status. Regulatory Lead the development of regulatory strategy for multiple and/or complex projects, from first-in-human to post-marketing application stage, including regulatory submission documents and Health Authority communications. Analyze and address complex regulatory issues, providing advanced regulatory solutions and guidance to cross-functional teams and regulatory leadership. Advise senior management on the status of global regulatory affairs strategies, tactics, practices, and procedures. Align with cross-functional teams to lead the development and management of project plans and timelines, ensuring all projects are appropriately prioritized and key goals are met on time. Influence the regulatory environment by actively participating in relevant conferences, trade associations, and industry and agency regulatory meetings. Remain current on the evolving regulatory landscape and provide regulatory policy and intelligence, including competitive issues that influence regulatory strategy. Qualifications Bachelor's degree in life sciences; advanced degree preferred. 10 or more years of progressive regulatory affairs experience in the US pharmaceutical industry. Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive Health Authority interactions, including well-organized preparation of cross-functional teams. Business-minded leader with the ability to think strategically and propose innovative solutions to regulatory problems. Advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling, and other activities related to the phases of drug development. Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies, and in guiding development teams with recommendations for change and refinement based on ongoing regulatory outcomes. Expert knowledge of global, regional, and local regulatory legislation, laws, procedures, and guidance for pharmaceutical development, including nonclinical and clinical requirements related to drug development, registration, and maintenance. Experience working within, and potentially managing, the Medical, Legal, and Regulatory review process of promotional materials preferred. Advanced knowledge of regulations and guidances related to the commercialization of pharmaceutical and biological products in the US; global experience preferred. Outstanding written and verbal communication skills, with the ability to influence at all levels of the organization. Excellent analytical, critical thinking, negotiation, and problem-solving skills. Strong project management skills with keen attention to detail and the ability to see the broader strategic picture. #J-18808-Ljbffr Kaye/Bassman International