Global Development Medical Director, Hematology Oncology in Hyderabad, भारत

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