Regulatory Affairs Manager - Remote

Overview

The Regulatory Affairs Manager at Amgen plays a crucial role in ensuring compliance with regulatory requirements for clinical trials and marketed products, supporting product strategies from a regional perspective.

In Short

• Manage regulatory submissions for clinical trials and marketing applications.
• Implement regulatory strategies and processes in compliance with legislation.
• Provide guidance for regional regulatory documents and meetings.
• Support label negotiation activities and product strategies.
• Conduct regulatory research to inform product advancement.
• Evaluate and communicate the impact of regional regulations.
• Work within a collaborative European General Medicine Regulatory team.
• Contribute to the lifecycle management of products in various therapeutic areas.
• Foster a diverse and inclusive workplace culture.
• Engage in professional growth opportunities within the organization.

Requirements

• Scientific degree and experience in regulatory affairs.
• Knowledge of regulatory principles and medicinal product legislation.
• Familiarity with clinical trial registration procedures.
• Experience in drug development and regional regulatory environments.
• Strong oral and written communication skills.
• Able to understand and convey scientific/clinical information.
• Skills in conflict resolution and proactive issue prevention.

Benefits

• Opportunities for professional growth and advancement.
• A diverse and inclusive community.
• Generous rewards plan including health and financial benefits.
• Flexible working arrangements including remote work options.
• Support for work/life balance.