Associate Regulatory Affairs

The Associate, Regulatory Affairs is primarily responsible for support of the Regulatory Promotion & Material Compliance group and Material Approval Compliance (MAC) processes by executing and overseeing functional processes to ensure quality and compliance.

US Regulatory Promotion Material Compliance (RPMC) is a function to ensure drug product and disease promotional communications to the health care community, patients, and the public are truthful and non-misleading. RPMC sits within Global Regulatory Affairs to provide operational regulatory leadership and expertise for all Amgen molecules.

The Associate, Regulatory Affairs will also be responsible for:

• Becoming Subject Matter Expert in the area of US Digital Asset Management triaging issues and developing best practices and value-based goals for process evolution
• Functional coordination and execution of regulatory health authority submissions in compliance with corporate standards and local regulatory requirements.
• Execution of the label change tactics for Material Approval Compliance (MAC) Processes
• Advise in developing Archive/Retrieval QC standards for Digital Asset Management (DAM)
• Supporting good relationships with Suppliers who archive and retrieve assets to ensure value for compliant operation of processes.
• Coordination and execution of Regulatory Affairs processes and deliverables to support functional and corporate goals

Key Activities:

• Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.
• Support label change process execution
• Coordinate process reviews and updates
• Disseminate relevant information to team(s) as appropriate
• Participate in functional regulatory process improvements initiatives
• Assist in authoring process training, standards and procedural documentation
• Oversee under direction the archive QC activities to ensuring proper categorization of assets/retrievals including monitoring of assets with Usage Rights for proper retrieval access including functional and practical knowledge of images, mechanicals, print specs, fonts, video, audio and digital reference files.
• Assist functionally in Healthcare Compliance activities where applicable
• Provide Records Management support for information requests
• Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on functional considerations in a timely manner
• Manage Outlook Inbox process notifications
• SharePoint collaboration tool experience and programming competency

Collaboration

• Collate, distribute and review Regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis.
• Partner where required with cross functional staff to support RPMC and Corporate goals

Basic Qualifications

Bachelor's degree

OR

Associates degree and 4 years of digital asset management experience in a regulated environment

OR

High school diploma / GED and 6 years of digital asset management experience in a regulated environment

Preferred Qualifications

• Bachelor's degree and at least 1 year of experience managing digital assets in a regulated environment
• Advanced Microsoft Office skills: Skype, Excel, PowerPoint, MS Word
• Ability to understand and communicate technical information with an analytical approach to problem solving
• Organizational and attention to detail skills
• Ability to recognize and escalate potential issues
• Document management and archiving practices
• Ability to understand and use graphic applications such as Excel (pivot tables and vlookup), Adobe Creative Suite / Cloud (Photoshop, InDesign, Illustrator), MAC software applications, Multimedia files, and Final Cut Pro, Premiere Pro, Audacity or other graphics and media editing software
• Basic understanding of remote networking to communicate between locations (Box, FTP, Server structure)
• Knowledge of Veeva Platform
• Basic understanding of copyright laws and best practices and database terminology, architecture and relationships
• Ability to multi-task and deal rapidly with multiple items in prioritized sequence while working in a highly visible environment.

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.
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.

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