Global Regulatory Operations, Regulatory Data & Analytics, Manager

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets 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
• Masters degree & 3 years of Regulatory experience OR
• Bachelors degree & 5 years of Regulatory experience OR
• Associates 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.

careers.amgen.com

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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