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Regulatory Affairs Manager - Material Approval and Compliance - United States  

Company managed [?] Still accepting applications

Posted on : 01 May 2017

Project Description

This position will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public. This position is also primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products.

Key Activities:

Amgen Material Approval and Compliance: evaluating proposed pieces and supporting evidence

Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen

Update the Promotions group on new learnings and key takeaways from courses, congresses, and tradeshows

Mentor Senior Associate and Manager level reviewers

Assesses promotional programs against Regulatory requirements


Basic Qualifications

Doctorate degree
OR
Master’s degree and 3 years of Regulatory and Compliance and/or Material Approval and Compliance experience
OR
Bachelor’s degree and 5 years of Regulatory and Compliance and/or Material Approval and Compliance experience
OR
Associate’s degree and 10 years of Regulatory and Compliance and/or Material Approval and Compliance experience
OR
High school diploma / GED and 12 years of Regulatory and Compliance and/or Material Approval and Compliance experience


Preferred Qualifications

Experience in reading, understanding, and applying promotional regulations to a constantly changing environment

Experience understanding and interpreting data/information and its practical application

Clinical knowledge/understanding

Analytical judgment

Negotiation/persuasion skills

Project management skills

Problem solving skills

Time management and organizational skills


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.