International Regulatory Lead - Remote

Overview

The International Regulatory Lead (IRL) Manager will provide regulatory leadership and expertise for International countries for one or more Amgen products, collaborating with various functions and local regulatory teams to optimize product development and regulatory approvals.

In Short

• Provide regulatory direction and expertise on international regulatory mechanisms.
• Plan regulatory submissions for clinical trials and marketing authorizations.
• Contribute to the development of international regulatory strategy documents.
• Manage the international label submission strategy and negotiate with cross-functional teams.
• Support local regulatory teams in triaging queries from health authorities.
• Participate as a member of the Global Regulatory Team.
• Maintain awareness of new legislation and regulatory policy.
• Perform regulatory research relevant to regional product advancement.

Requirements

• Doctorate degree or relevant regulatory experience.
• Knowledge of international regulatory environment for clinical trial applications.
• Comprehensive knowledge of regulatory principles.
• Ability to resolve conflicts and develop beneficial outcomes.
• Strong communication skills, both oral and written.
• Ability to work effectively with global and local teams.
• High degree of initiative and self-motivation.
• Good negotiation and influencing skills.

Benefits

• Work with a leading biotechnology company.
• Opportunity to impact patients' lives positively.
• Collaborative work environment.
• Professional growth and development opportunities.