Regulatory Affairs Manager – CMC
Posted: January 20, 2017
Reference ID: R-32470
This position can be located in Thousand Oaks, Cambridge or Rhode Island.
The Global Module 3 Authoring Process (GM3AP) Manager position is tasked with support of the program, supporting progress on top priority items and marketing applications (MA) preparation at key times. The Manager will support the Business Process Owner (BPO) by executing on responsibilities for the process, tools and strategies which document regulatory requirements for preparation of global core filing sections. The position will support the BPO in preparing updates for the Executive Sponsors, functional area leadership teams, functional area forums and platforms teams, product teams, and CMC departmental teams.
Support of Global Module 3 Authoring Process
Support BPO in communication and education
Supports Lifecycle management and continuous improvement
Supports BPO in keeping guides and tools current
Set up and lead meetings
Master's degree and 3 years of regulatory, CMC, manufacturing, testing or distribution experience
Bachelor's degree and 5 years of regulatory, CMC, manufacturing, testing or distribution experience
Associate's degree and 10 years of regulatory, CMC, manufacturing, testing or distribution experience
High school diploma / GED and 12 years of regulatory, CMC, manufacturing, testing or distribution experience
Project Management skills
Knowledge of, and experience with, Module 3 preparation throughout phases of development
Knowledge of Operations and Quality functions, Product Delivery Teams, and supporting functions, such as Supply Chain
Strong understanding of GM3AP principles, practice and vision
Ability to communicate effectively at a variety of levels
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using 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 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, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.