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About the Role

In this vital role, you will interface with Amgen's global, international, site, and biosimilars Regulatory Affairs (RA CMC) teams and the device team for specific strategies or activities that impact a product. You will be responsible for varying levels of product support, including leading projects, based upon your experience level. The RA CMC facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout the product lifecycle.

Responsibilities

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
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 report status of activities and projects to teams and department
Participate in cross-functional special project teams

Requirements

Degree educated
Background in CMC related functions (e.g., Quality, Manufacturing, etc.) 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

Skills

Project management
Organizational skills
Oral communication
Written communication

Location

Cambridge
Uxbridge

Work Type

Flexible from home
Regular office work

Experience Level

Senior Associate
Experienced professional

Education Level

Degree educated

Benefits

Comprehensive regulatory training
Buddy system
Exposure to a wide variety of projects and therapy areas
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

About the Company

Amgen's shared mission is to serve patients.
Amgen is one of the world's leading biotechnology companies.
Amgen is a global collaborator researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Amgen uses tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies.
Amgen has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Equal Opportunity

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.
Amgen 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.