Regulatory Affairs Manager - Data Automation - Remote

Overview

Amgen is seeking a Manager, Regulatory Affairs CMC – Data Automation to drive digital transformation and automation within CMC submissions, contributing to the future of regulatory affairs.

In Short

• Join Amgen’s mission to serve patients living with serious illnesses.
• Implement automation and digital tools for regulatory CMC documentation.
• Develop standardized templates for compliant submissions.
• Contribute to AI and structured content/data management projects.
• Coordinate with cross-functional teams for alignment on automation standards.
• Monitor industry trends in digital and regulatory innovations.
• Design automated solutions for data extraction and integration.
• Participate in training on digital tools and regulatory automation.
• Assist in regulatory interactions regarding digital transformation.
• Foster an inclusive environment within the Amgen team.

Requirements

• Doctorate or Master’s degree with relevant experience.
• Experience managing a team in regulatory or compliance.
• Knowledge of ICH guidance and global regulatory requirements.
• Experience in digitalization, automation, or software development.
• Background in manufacturing, process development, or quality assurance.
• Hands-on experience with Veeva Vault platforms.

Benefits

• Competitive benefits and collaborative culture.
• Support for professional and personal growth.
• Comprehensive Total Rewards Plans aligned with industry standards.