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Job Detailsnbowman2022-03-07T14:23:07+00:00
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REGULATORY AFFAIRS MANAGER – CMC

US, CA,Los Angeles


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Job ID |R-151836



Category |Regulatory



Post Date |October 3, 2022

What one piece of advice would you give others looking to join Amgen?
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Transcript

Hi, everyone, Judy Coates from Amgen South Africa. I am the senior manager for
regulatory and government affairs. I was asked to share a snippet of advice and
I believe always share what comes first to mind, so that's what I'm gonna do. If
you try to apply for an opportunity at Amgen and you're not successful the first
time around, try and try again, never give up. If you believe in your heart that
you're aligned with the values of what Amgen represents and you would like to be
a part of the Amgen journey, align with Amgen as an external stakeholder. Learn
more about the business, learn about the culture, learn about the people, and
when the right opportunity comes along, you will be perfectly positioned to snap
it up and enjoy becoming part of the Amgen family. I wish you all a best in your
career endeavors. Thank you.


Video length: 47 seconds0:47
Hi, everyone, Judy Coates from Amgen South Africa. I am the senior manager for
regulatory and government affairs. I was asked to share a snippet of advice and
I believe always share what comes first to mind, so that's what I'm gonna do. If
you try to apply for an opportunity at Amgen and you're not successful the first
time around, try and try again, never give up. If you believe in your heart that
you're aligned with the values of what Amgen represents and you would like to be
a part of the Amgen journey, align with Amgen as an external stakeholder. Learn
more about the business, learn about the culture, learn about the people, and
when the right opportunity comes along, you will be perfectly positioned to snap
it up and enjoy becoming part of the Amgen family. I wish you all a best in your
career endeavors. Thank you.
Judy
Snr Manager Regulatory and Government Affairs

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.



Regulatory Affairs Manager – CMC





LIVE

What you will do

Let’s do this. Let’s change the world. In this key role you will manage an
external service provider and internal staff members within the Regulatory
Optimization of Tactical and Strategic Support (Roots2) team. ROOTS2 is a team
within the Global CMC Regulatory Affairs department responsible for execution of
CMC submissions across countries, using standardized procedures to improve
efficiency. This role will also manage, lead, and develop CMC regulatory staff
in US and/or UK. This role requires a strong understanding of the CMC regulatory
requirements across countries, phases of development and indications for
biologic, synthetic, and/or biosimilar products as well as the ability to
coordinate resources and tasks across Amgen global sites.

Key responsibilities of this CMC Regulatory Manager role include:

 * Oversight of an external service provider including, but not limited to,
   direct interactions with the vendor, oversight of resources and ways of
   working

 * Supervising assigned team members with respect to management, training, and
   resource planning

 * Support of CMC filings including Investigational New Drug (IND)/Clinical
   Trial Applications (CTAs), Marketing Application/Authorization, post-approval
   supplement/variations, renewals and responses to agency request for
   information across countries

 * Collaboration with leadership across CMC Regulatory functions and other
   functional leaders

 * Leading process improvements and documenting CMC Regulatory processes

 * Providing expertise and guidance to interdepartmental and cross-functional
   teams

 * Coaching and supporting junior staff’s career development





WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.
The [vital attribute] professional we seek is a [type of person] with these
qualifications.



Basic Qualifications:

 * Doctorate degree; OR Master’s degree and 3 years of Regulatory CMC or
   Compliance and/or Quality experience; OR Bachelor’s degree and 5 years of
   Regulatory CMC or Compliance and/or Quality experience; OR Associate’s degree
   and 10 years of Regulatory CMC or Compliance and/or Quality experience

 * CMC specific regulatory knowledge and an understanding of manufacturing,
   process development, quality control, or quality assurance related to
   biologics, small molecules, biosimilars, and/or combination products

 * Preparation of global CMC submissions across all phases of development

Preferred Qualifications:

 * Degree in life sciences, biochemistry, or chemistry

 * Experience in leading Global regulatory CMC submissions and an understanding
   of global requirements and ICH guidance

 * Experience with manufacturing, process development, quality control, or
   quality assurance

 * Experience with training and/or managing staff

 * Project management experience

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also 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 increase 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.


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.

We will ensure that individuals with disabilities are provided 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 accommodation.



Amgen requires all staff in the United States, Puerto Rico and Canada 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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