Regulatory Affairs Mgr

Manager - International Regulatory Lead for Amgen's international regulatory affairs team, providing regulatory leadership and expertise for international countries.

Requirements

• Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience.
• Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products.
• Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes.
• General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Cultural awareness and sensitivity to achieve results across country, regional and international borders.
• Strong communication skills, both oral and written.
• Ability to understand and communicate scientific/clinical information.
• Ability to work effectively with global, local and virtual teams.
• High degree of initiative and self-motivation.
• Planning and organizing abilities.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.
• Good negotiation and influencing skills.

Benefits

• EQUAL OPPORTUNITY STATEMENT
• Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.