Regulatory Affairs Manager
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.
Regulatory Affairs Manager
What you will do
Lets do this. Lets change the world. In this vital role you will assume a CMC Global regulatory role for products that are in the late phase clinical through commercialization.
- Advance products by preparing the product for licensure through commercialization activities
- Ensure regulatory strategy and deliverables are aligned with project teams and business objectives
- Manage late-stage pivotal clinical filings
- Monitor, evaluate and interpret applicable regulatory requirements to assure compliance with internal and external standards
- Lead cross-functional teams in development and submission of documents, including responses to questions from regulatory authorities
- Utilizequalitysystem knowledge fortasks related todeviations and change controlassessments
- Submission content knowledge for CTAs and Marketing Applications
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a partner with these qualifications.
- Doctorate degree
- Masters degree and 3 years of Regulatory CMC & Compliance and/or Quality experience Or
- Bachelors degree and 5 years of Regulatory CMC & Compliance and/or Quality experience Or
- Associates degree and 10 years of Regulatory CMC & Compliance and/or Quality experience Or
- High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality experience
- 3+ years experience in domestic and/or international regulatory submissions, project management and product development in the Pharmaceutical/Biotechnology industry, preferably CMC
- Degree in life sciences, biochemistry, chemistry or related field
- Experience managing execution of multiple projects
- Knowledge and understanding of different phases of drug development
- Results-oriented and have a track record of completing deliverables on time with high quality
- Excellent communication (both written and verbal), presentation and facilitation skills
- Ability to develop solutions to technical and organizational issues in order to improve performance and efficiency
- Ability to work independently and proactively
- Strong digital literacy, including word processing, Excel, database/document repository and project management software
- Ability to foster a strong team environment, while recognizing the needs of team leaders and key stakeholders
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.