Opportunity Details

The client is seeking a Temporary Regulatory Affairs Strategy Director to lead the systematic collection, analysis, and dissemination of regulatory intelligence that informs policies, processes, and practices. The role will support subject matter experts in assessing how evolving global regulatory requirements may impact the organization and in translating regulatory changes into actionable guidance. The director will develop and execute regulatory impact assessments and action plans to support ongoing compliance and continuous process improvement.

This position will serve as a key cross-functional partner across Research and Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology to drive enterprise-wide implementation of regulatory expectations. Responsibilities include monitoring the external regulatory environment to identify emerging intelligence such as regulatory updates and relevant competitor approvals and submissions, establishing relationships and networks to stay current on regulatory interpretation, and interpreting intelligence to assess impact and advise stakeholders and leadership. The role will also participate in cross-departmental discussions to ensure timely identification of relevant regulatory information aligned to strategic priorities.

The director will lead regulatory action planning based on new intelligence, updating policies, processes, and procedures as needed, and will support audits and inspections to demonstrate compliance with regulatory systems and procedures. Qualifications include a bachelor’s degree with at least thirteen years of relevant experience (or a master’s degree with at least eleven years, or a PhD with at least eight years), regulatory affairs and oncology experience within a pharmaceutical company, extensive knowledge of regulatory frameworks and industry practices, strong communication and presentation skills, and proven leadership of cross-functional teams. Additional expectations include the ability to manage multiple priorities, proactively assess workload, trends, and risks, and knowledge of regulatory systems, compliance standards, and audit processes.