Sr Manager Regulatory Affairs, CMC Site Sr. Manager CMC (US-Remote)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Sr Manager Regulatory Affairs, CMC Site Sr. Manager CMC (US-Remote)

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for the strategy and execution of the site-specific aspects including assessment of changes for regulatory reportability, preparation of CMC post-market supplements and facility registrations, CMC sections of annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams.

Specific responsibilities include but are not limited to:

• Interface with site functions, including Operations and Quality, to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity.

• Support the Amgen Thousand Oaks site relating to the manufacture of clinical, commercial, biological and small molecule products.

• Is responsible for site-specific change control regulatory assessments with input from the CMC Global and International representatives

• Serve as the key RA CMC representative to provide regulatory input to product deviation investigation teams.

• Lead RA CMC activities at the site, including supervision of direct reports.

• May facilitate issue resolution relating to site GMP documentation or establishment registration, including Structured Product Labeling

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The regulatory affairs professional we seek is a motivated manager with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of directly related experience OR

Masters degree and 6 years of directly related experience OR

Bachelors degree and 8 years of directly related experience

Preferred Qualifications:

• CMC-specific regulatory knowledge & experience with working knowledge of product lifecycle changes impacting CTAs and Mas

• Experience in manufacture, testing, or distribution of clinical and/or commercial products or related Quality or Regulatory (CMC) functions in Pharmaceutical/Biotech industry

• Understanding and application of principles, concepts, theories and standards of scientific/technical field

• Experience managing of multiple projects and people management are highly desired.

• Knowledge and understanding of different phases of drug development.

• Ability to develop solutions to technical and organizational issues in order to improve performance and productivity

• Proven track of strong team environment building, while recognizing the needs of team leaders and key stakeholders

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization

• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

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 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 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.

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.