Summary from listing
Astellas is seeking a global Lead to provide thought leadership and operational leadership for Regulatory Affairs and Pharmacovigilance data governance and compliance. The role leads RA and PV data capabilities, submission and safety reporting systems, data quality and governance KPIs, vendor and system implementations, inspection readiness, audits, and cross-functional initiatives. It also manages staff and consultants, establishes data ownership and stewardship, and ensures alignment with regulatory standards and enterprise data governance. The position requires at least 10 years of global regulatory operations experience and at least 6 years managing people or teams in a cross-cultural setting.
