Associate Regulatory Affairs

Roles and Responsibilities :

• Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
• Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
• Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
• Leverage company subscriptions to provide art procurement services in support of Amgen s marketing initiatives.
• Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen s various data repositories.
• Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
• Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
• Lead and facilitate Webex / MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
• Create infographics and presentation materials; perform technical editing and proofreading of process documentation.

Required Knowledge and Skills :

Preferred Knowledge and Skills :

Skills Required

Regulatory Compliance, Data Analysis, Clinical Trials, Quality Assurance, Risk Assessment