Manager, Global Regulatory Affairs, Accumulus SPO
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.
Manager, Global Regulatory Affairs, Accumulus SPOLive
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for Tactical and strategic activities in support of the Cloud Based Filing and Review efforts of Accumulus and specifically the CMC Use Case.
- Tactical and strategic RA-CMC activities related to Amgen's internal CMC Authoring and Data Automation
- Influence internally and externally in support of business objectives related to intelligent automation (CMC Automation/Accumulus)
- Tactical actions using external regulatory and industry knowledge to support projects/teams
- Working internally to develop regulatory engagement strategy and alignment relative to new technologies/innovation/regulation/guidance
- Educating staff, sharing standard methodologies to influence the external environment as related to CMC Automation
- Promote Amgen short and long-term CMC automation initiatives in alignment with Amgen and Accumulus with an emphasis on CMC data automation
- Support Accumulus engagements with Health Authorities, Industry Groups and Accumulus Sponsor companies in support of the CMC Use Case
- Further develop internal expertise and talent regarding CMC Automaton including streamlining submission authoring content to accelerate timelines
- Partner effectively on intelligent automation and Accumulus with internal and external partners (PD, Quality, GRAAS, R&D Policy)
- Act as a conduit between Amgen and Accumulus stake-holders
- Champion proactive influencing in line with Amgen and Accumulus initiatives and objectives
- Encourage staff awareness and build a culture of active participation and learning by sharing information externally and internally within RA-CMC
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The dedicated professional we seek is a collaborator with these qualifications.Basic Qualifications
- Doctorate degree OR
- Masters degree and 2 years of directly related experience OR
- Bachelors degree and 4 years of directly related experience OR
- Associates degree and 8 years of directly related experience Or
- High school diploma / GED and 10 years of directly related experience
- Hands on experience and/or familiarity with regulatory submissions, ICH Electronic Module 3 Common Technical Document
- Proven experience in preparing sections of Common Technical Documents which are suitable for successful global registrations
- Experience in regulatory program management, pharmaceutical operations, development, manufacture, testing or distribution in the Pharmaceutical/Biotech industry
- Regulatory CMC experience, specifically associated with Module 3 development
- Experience with CMC External Engagement, scientific publications, Agency engagements
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request an accommodation.
Join UsIf 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.