Sr Associate Regulatory Affairs - CMC

Sr Associate Regulatory Affairs - CMC

What you will do

• Interface with the Amgen global, international, site and biosimilars Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) teams and the device team for specific strategies or activities that impact a product.
• Take responsibility for varying levels of product support, including leading projects, based upon experience level.
• Contribute as a key member of the global regulatory CMC product team.
• Interact with authors/reviewers and subject matter experts regarding the 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.
• Document and archive CMC submissions and related communications in the document management system.
• Initiate and maintain CMC product timelines at the direction of the product lead.
• Interface with the regulatory operations team.
• Train staff on select CMC procedures and systems.
• Provide status reports of activities and projects to teams and the department.
• Participate in cross functional special project teams.

You will be part of a supportive and diverse team, where comprehensive regulatory training and a buddy system are provided, along with exposure to a wide variety of projects and therapy areas.

What we expect of you

• Degree educated.
• Background in CMC related functions (e.g., Quality, Manufacturing) with limited or no prior Regulatory Affairs experience.
• Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast paced learning environment.
• Developed project management and organizational skills.
• Strong and effective oral and written communication skills.

What you can expect of us

Vast opportunities to learn and advance across our global organization. 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.

Location

Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

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.