HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr Associate Regulatory Affairs - CMC

Live

What you will do

Let’s do this. Let’s change the world. In this key role you will collaborate with the Amgen Regulatory Affairs CMC global and regional teams, site regulatory, the Biosimilars unit as well as the device team for specific strategies or activities that impact a product. The person taking this role will be responsible for varying levels of product support, including leading projects, based upon their experience level. Key responsibilities include:

• Participate as a key member of the global regulatory CMC product team

• Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions

• Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications

• Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements

• Document and archive CMC submissions and related communications in the document management system

• Initiate and maintain CMC product timelines at the direction of product lead

• Collaborate with the regulatory operations team and participate in cross-functional special project teams

• Train staff on select CMC procedures and systems

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly competent individual we seek is a go-getter with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device experience, and/or Scientific experience OR

Associate’s degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR

High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience

Preferred Qualifications:

• BS degree in Life Science

• Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development

• Regulatory CMC specific knowledge and experience

• Developed project management and organizational skills

• Strong and effective oral and written communication skills

Thrive

What you can expect of us

As we work to develop treatments that improve the health of others, we also work to support our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $83,292 - 104,433.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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 cancers, 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.