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Senior Associate Regulatory Labeling - United States  

Amgen (company)

Posted on : 07 May 2017

Project Description

As part of Global Labeling (CGL), and under the supervision of the Global Labeling Process Management Director, the Global Labeling Process Management, Associate supports the Global Labeling Process Management team to manage labeling Process Management activities. The Global Labeling Process Management, Associate also supports oversight of document management for regional documents, core labels and other related documents and Labeling vendor management.

The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.


Triage requests through the LEXA tool for timeline waivers and deviations from core or reference label content

Track and report on bundling of core documents to Labeling Strategists and RA

Track and report on upcoming CDS/Global labeling changes and monitors project deadlines

Provide US, and other regional labeling operational support, including formatting, templates, SPL, QC, translations support, including translation memory management

Support local regulatory by providing guidance in maintaining data in LEXA and documents EPIC, including clarification of processes

Support management of global labeling vendors to ensure established SLA’s are met (e.g. translations, Quality Control checks, etc.)

Basic Qualifications

Master’s degree
Bachelor’s degree and 2 years of Regulatory, Compliance or Quality experience
Associate’s degree and 6 years of Regulatory, Compliance or Quality experience
High school diploma / GED and 8 years of Regulatory, Compliance or Quality experience

Preferred Qualifications

Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering

Works well independently and within teams

Use of document management tools

Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect

Time and project management skills

Ability to take initiative and drive results

Tolerance for ambiguity

Proficiency in anticipating and resolving problems

Oral and written communication and presentation skills

Relationship management

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.