Global Regulatory Lead - Obesity and Related Conditions

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Regulatory Lead - Obesity and Related Conditions

Live

What you will do

Let’s do this! Let’s change the world!

Amgen is seeking a Global Regulatory leader with expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. The purpose of this role is:
• 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))

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Key responsibilities

• 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.
• Competencies:

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic 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

• Organizational savvy

• Negotiation skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on el