Regulatory Affairs Strategy Director

Job Title: Regulatory Affairs Strategy Director Job Description The Regulatory Affairs Strategy Director leads the systematic collection, analysis, and dissemination of global regulatory intelligence to inform enterprise policies, processes, and practices. This role enables subject matter experts to understand the impact of evolving regulatory requirements, translate regulatory changes into actionable guidance, and ensure ongoing compliance and continuous improvement. The director serves as a key cross‑functional partner across Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology to drive consistent, enterprise‑wide implementation of regulatory expectations. Responsibilities Lead the systematic collection, analysis, and dissemination of global regulatory intelligence to inform internal policies, processes, and practices. Monitor the external regulatory environment to identify emerging regulatory intelligence, including regulatory-related news, competitor product approvals, and submissions relevant to the organization. Identify, analyze, and proactively communicate regulatory developments and their potential impact to key stakeholders and leadership. Establish and maintain formal and informal networks to stay current with regulatory intelligence, trends, and interpretation. Interpret regulatory intelligence to assess its impact on the organization and provide clear, actionable advice to stakeholders and leadership. Monitor organizational strategic priorities and participate in cross-departmental discussions to ensure timely identification of targeted regulatory intelligence needs. Lead Regulatory Affairs action planning to update policies, processes, and procedures based on new regulatory intelligence and surveillance information. Develop, oversee, and monitor the completion of regulatory intelligence-related impact assessments and action plans to ensure timely and effective implementation. Establish cross-functional relationships and internal networks to plan impact assessments and coordinate action implementation resulting from new regulatory intelligence. Serve as the business owner for the enterprise regulatory intelligence system, ensuring it effectively supports regulatory monitoring and decision-making. Establish processes and performance measures to ensure Regulatory Affairs conformance with quality procedures and internal standards. Support audits and inspections by providing evidence of compliance and demonstrating robust regulatory intelligence and action planning processes. Develop and manage plans, establish timelines, and set performance standards for Regulatory Affairs intelligence and strategy activities. Proactively balance multiple commitments, overcome challenges, and ensure completion of multiple complex activities while delivering high-quality work. Apply extensive knowledge of the regulatory framework, industry drivers, and best practices to develop innovative approaches and manage complex regulatory work. Provide clear and effective verbal and written communication, including timely information updates and presentations to cross-functional groups. Demonstrate strong interpersonal skills by accommodating differing views and influencing stakeholders toward agreed-upon resolutions. Effectively lead and manage a high-performing team, facilitating alignment and achievement of common objectives that support departmental and organizational goals. Engage internal and external stakeholders to establish productive, collaborative relationships that support regulatory strategy and compliance. Provide regulatory expertise to cross-functional teams, gathering, analyzing, and applying key information to solve complex problems. Evaluate longer-term consequences of regulatory decisions and actions, ensuring alignment with organizational goals and strategic direction. Proactively assess workload, trends, tasks, and priorities within the area of responsibility to optimize resource allocation and delivery. Plan and execute multiple concurrent activities, considering alternative methods and contingency plans to avoid potential issues. Design and implement solutions to address project-level challenges, taking into account broader organizational impact and long-term implications. Act with integrity to build trust within the team and across the organization while executing on team objectives that contribute to regulatory and business success. Essential Skills Extensive experience in Regulatory Affairs within the pharmaceutical industry. Regulatory Affairs and oncology experience with a pharmaceutical company. Dee