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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. Join us.

Director, Global Regulatory Affairs CMC

Live

What you will do

Let’s do this. Let’s change the world. In this vital role, you will be responsible for the execution and coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to lead all aspects of the successful execution and implementation of regulatory strategy related to drug development up through Phase III and initiation of commercialization.

The Director RA Global CMC Technical Lead is responsible for highly complex and business-critical projects including Global registrations of Amgen's innovative pipeline with a focus on accelerating drug development. In addition, the Technical Lead oversees other RA CMC staff, and is the lead in providing global strategic and tactical guidance to CMC product teams for developing clinical filing strategies, marketing application guidance, and for leading agency interactions including content related to in-person meetings, response to questions and commitments.

The Director RA Global CMC will lead a Global CMC regulatory team, associated products, and programs, in addition to supporting the Product Development and Global Regulatory Teams. In this function, you will develop the regulatory strategy and communication of regulatory options, risks and issues to Global Regulatory and Operations leadership. You will facilitate communication, collaboration, and coordination between Global Regulatory CMC Centers, the site and regional CMC teams as well as device regulatory. The Director will lead communication with Health Authorities on all CMC issues. This role will be responsible for the development, influence and execution of Global regulatory strategy with respect to preparation of submissions to ensure consistency through the Amgen platforms.

Additional Responsibilities of the Director RA Global CMC Technical Lead:

• Effectively communicate the RA CMC options and risks to senior leadership and cross functional teams to gain agreement on regulatory directions and positions

• Establish core standards for RA CMC regulatory documentation

• Provide strategic regulatory input and regulatory risk assessments for product and project teams

• Act as the RA CMC technical lead for complex and innovative product portfolio through development

• Provide guidance, coaching and mentoring to RA CMC staff

• Manage priorities, resources and budget

• Identify and develop critical RA CMC processes in support of Amgen's Global Module 3 Authoring Process (GM3AP)

• Identify the need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance

• Report needs for process changes and contributes to process improvements

• Incorporate changes in external regulatory guidance into CMC strategy and guidance for product teams, report issues, progress and metrics to RA CMC product team management and/or RA CMC Functional Lead

• Represent RA CMC on Operations steering committees and review boards as needed

Win

What we expect of you

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

Basic Qualifications

Doctorate degree and 4 years of Regulatory experience OR Master’s degree and 8 years of Regulatory experience OR Bachelor’s degree and 10 years of Regulatory experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Master’s degree

• Ability to lead and build effective teams

• Strong communication skills - both oral and written

• Ability to anticipate and mitigate against future strategic issues & uncertainties

• Ability to resolve conflicts and develop a course of action

• Cultural awareness and sensitivity to achieve global results

• Planning and organizing abilities

• Managing multiple activities

• Making complex decisions

• Problem solving abilities

• Setting priorities

• Multi-disciplinary

• Dealing with ambiguity

• Organizational savvy

• Action orientated

• Conflict management skills

• 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 our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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