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Sr Associate Regulatory Affairs - Cmc - (Open To Remote)

Company

Amgen
Address , Los Angeles, Ca
Employment type FULL_TIME
Salary $83,292 - $104,433 a year
Expires 2023-06-24
Posted at 1 year ago
Job Description
Career Category
Regulatory
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
  • Document and archive CMC submissions and related communications in the document management system
  • Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
  • 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
  • Initiate and maintain CMC product timelines at the direction of product lead
  • Train staff on select CMC procedures and systems
  • Collaborate with the regulatory operations team and participate in cross-functional special project teams
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
  • Regulatory CMC specific knowledge and experience
  • Developed project management and organizational skills
  • Strong and effective oral and written communication skills
  • Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
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:
  • Flexible work models, including remote work arrangements, where possible
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • 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.
  • Stock-based long-term incentives
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
.
Salary Range
83,292.00 USD - 104,433.00 USD