Regulatory Affairs CMC Senior Associate

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Regulatory Affairs CMC Senior Associate

What you will do

Lets do this. Lets change the world. Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients. Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and implementing regulatory strategies and leading effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate for the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission implementation for Amgen products across phases of development, modality and countries.

In this vital role you will partner the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.

• Contribute 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, postmarket 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
• Interface with the regulatory operations team
• Train staff on select CMC procedures and systems
• Provide report status of activities and projects to teams and department
• Participate in cross-functional special project teams
• Support and coordinate CMC country specific document signature and authentication including archiving and dispatching to health authorities

What we expect of you

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

Masters degree

Bachelors degree and 2 years of related experience

Associates degree and 6 years of related experience

High school diploma / GED and 8 years of related experience

• BS degree in Life Science
• Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
• Regulatory CMC specific knowledge and experience
• Mature project management and organizational skills
• Strong and effective oral and written communication skills

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.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.