Global Regulatory Lead

Description

• To lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department
• To develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
• To provide regulatory expertise and guidance to product teams (eg, Product Team (PT), Evidence Generation Team (EGT), Global Safety Team (GST)
• Demonstrated ability to lead teams
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Understanding of regulatory activities and how they affect projects and processes
• Ability to anticipate and mitigate against future strategic issues & uncertainties
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome – influencing and negotiation skills
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.

Qualifications

Doctorate degree and 5 years of regulatory experience in biotech or science
OR
Master’s degree and 8 years of regulatory experience in biotech or science
OR
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Preferred Qualifications: Preferred Qualifications:

• Contemporary obesity experience desired
• Demonstrated ability to lead regulatory aspects of highly complex programs in late development
• Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
• Ability to lead and build effective teams
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and mitigate against future strategic issues and uncertainties
• Ability to resolve conflicts and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and manage multiple activities
• Ability to make complex decisions and solve problems
• Ability to deal with ambiguity