Assoc Regulatory Affairs Strategy Director (Oncology)

Role: Senior Regulatory Affairs professional responsible for developing and executing global regulatory strategies aligned with asset and corporate goals. Primary objectives include ensuring timely, compliant submissions and providing regulatory guidance to study and asset teams. Responsibilities encompass interacting with authorities, conducting regulatory intelligence, preparing and maintaining submissions (e.g., INDs, NDAs, BLAs), reviewing clinical documentation, and liaising with external vendors and internal stakeholders. Qualifications: Bachelor's degree with 11+ years, Master's with 9+ years, or PhD with 5+ years of relevant experience; extensive knowledge of regulatory frameworks, strong communication, and leadership skills. High-Value: Experience in biopharma regulatory processes, including global submissions, clinical trial documentation, and cross-regional compliance (Europe, Asia). Knowledge of health authority interactions, risk assessments, and regulatory strategies for early to late-stage development. Work setup involves travel (~10%) and coordination across multidisciplinary teams.