Global Regulatory Affairs Director - Oncology - Remote

Overview

The Global Regulatory Affairs Director at Amgen will lead the Regulatory Affairs team in the Oncology Therapeutic Area, developing comprehensive regulatory strategies and ensuring effective interactions with regulatory agencies to support product development and lifecycle management.

In Short

• Lead Global Regulatory Teams in Oncology.
• Develop global regulatory product strategies.
• Ensure compliance with worldwide regulatory requirements.
• Provide regulatory expertise to product teams.
• Communicate regulatory strategies across the organization.
• Monitor global regulations and their impact.
• Attend regulatory agency meetings.
• Guide teams on regulatory submissions and approvals.
• Assess and incorporate regulatory mechanisms into strategies.
• Foster effective agency communications.

Requirements

• Doctorate degree with 4 years, or Master’s with 8 years, or Bachelor’s with 10 years of regulatory experience in biotech or science.
• Supervisory experience preferred.
• Contemporary oncology experience desired.
• Strong oral and written communication skills.
• Ability to resolve conflicts and develop action plans.
• Cultural awareness and sensitivity.
• Planning and organizing abilities.
• Decision-making and problem-solving skills.
• Negotiation skills.
• Ability to manage multiple activities.

Benefits

• Comprehensive employee benefits package.
• Generous retirement and savings plan.
• Group medical, dental, and vision coverage.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote work arrangements.
• Career development opportunities.
• Support for work/life balance.