Amgen Global Regulatory Operations, Regulatory Data & Analytics, Manager in Thousand Oaks, California
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
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
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
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
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
for a career that defies imagination
Objects in your future are closer than they appear. 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.