Regulatory Affairs CMC Manager - Remote

Overview

The Regulatory Affairs CMC Manager at Amgen will play a pivotal role in driving process improvements and ensuring consistency across Global CMC & Device Regulatory Affairs, contributing to the mission of serving patients through innovative biotechnology solutions.

In Short

• Lead the Submission Process, Planning, and Management (SPPM) team.
• Drive continuous improvement of processes and tools.
• Facilitate communication across regulatory affairs to ensure process awareness.
• Develop and maintain training materials for staff.
• Ensure consistent use of processes and tools across the department.
• Participate in cross-functional special project teams.
• Support new hire onboarding programs.
• Manage or oversee staff as necessary.
• Collaborate with global teams to enhance operational effectiveness.
• Foster a culture of quality and consistency in all processes.

Requirements

• Doctorate or Master’s degree with relevant experience in CMC.
• Experience in Regulatory Affairs, Manufacturing, or Quality Assurance.
• Working knowledge of global submission requirements.
• Experience in developing SOPs or training programs.
• Project management certification is a plus.
• Strong organizational and communication skills.
• Ability to manage multiple priorities effectively.
• Experience in a fast-paced, deadline-driven environment.
• Collaboration skills across diverse teams.
• Familiarity with regulatory systems or tools.

Benefits

• Competitive salary and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative and innovative work culture.
• Opportunities to make a lasting impact on patient lives.
• Inclusive environment that respects diversity.
• Commitment to employee well-being.
• Access to training and development resources.
• Flexible work arrangements.
• Support for onboarding and continuous improvement initiatives.
• Engagement in meaningful projects that advance science.