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Sr Associate Regulatory 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.
SR ASSOCIATE REGULATORY AFFAIRS
WHAT YOU WILL DO
Let’s do this. Let’s change the world. In this vital role you will interface with the Amgen RA 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 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, 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
- 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
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.
- Master’s degree Or
- Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device 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
- 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
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 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
FOR A CAREER THAT DEFIES IMAGINATION
Objects in your future are closer than they appear. Join us.
Equal 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.
Learn more here
Job posted: 2022-04-24