Amgen seeks a regulatory manager to lead international product approvals and lifecycle management across multiple countries. The role involves developing regulatory strategies, optimizing product development pathways, and coordinating with global and local teams to ensure consistent compliance and market alignment.

Responsibilities

Lead development of international regulatory strategy and coordinate global regulatory planning for assigned products
Plan and oversee regulatory submissions including clinical trials and marketing authorization applications
Direct product labeling strategy negotiations with cross-functional teams and health authorities
Support local regulatory teams with query triage, documentation maintenance, and agency meeting coordination
Maintain awareness of evolving regulatory legislation, policy, and technical guidance impacting product advancement

Requirements

Doctorate degree with 6+ years regulatory experience, or Master's with 8+ years, or Bachelor's with 10+ years
Comprehensive understanding of regulatory principles, procedures, and international registration requirements
Knowledge of national legislation and drug development processes relevant to medicinal products
Strong written and oral communication skills with ability to articulate scientific and clinical information
Negotiation and influencing skills with demonstrated ability to resolve conflicts constructively
Cultural awareness and sensitivity for cross-border collaboration across regions and countries

Global Development Medical Director, Hematology Oncology

Start with your email