Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Global Regulatory Operations, Regulatory Data & Analytics, Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide support through line-management and as an individual contributor to ensure the execution of RDA team objectives

Responsibilities:

• Lead regionally aligned RDA team including line-management of staff
• Day-to-day issues management and workload balancing
• Ensure timely data entry, administration of, and reporting from Regulatory Submissions and Document Information Management System (RSDIMS)
• Liaise with Regulatory Representatives/CMC and publishing teams to ensure seamless and consistent approach to document management and maintenance of tracking system
• Hiring, coaching, mentoring, and development of staff to take on additional responsibilities and advance in their career path
• Create and contribute to the development and roll out of training and process documentation
• Manage and maintain key performance (KPI) and compliance indicators (KCI)
• Maintain team SharePoint sites and associated documentation
• Represent Regulatory Operations on global workstreams for process improvements in document management and regulatory information tracking
• Contribute to Information System enhancements and software update projects related to document management and regulatory information tracking
• Ensuring Regulatory compliance with SOPs and Regulatory authorities
• Provide training, mentoring and support to other functional areas, including vendors
• Collaboration with external partners/outsourced CROs
• MAP documentation and development of direct reports through CDP Process (Personal Development)
• Project documentation and metrics dissemination
• Identification and onboarding of FTE resources
• Create and participate in the development of processes, policies, guidelines, & SOPs

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR
• Master’s degree & 3 years of Regulatory experience OR
• Bachelor’s degree & 5 years of Regulatory experience OR
• Associate’s degree & 10 years of Regulatory experience OR
• High school diploma/GED & 12 years of directly related experience

Preferred Qualifications:

• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• Complex understanding of the Veeva Vault system

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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