Regulatory Data & Systems Manager

Job Description

The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis / administration, regulatory affairs, and project management.

Roles & Responsibilities :

• System Administration : Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements.
• Regulatory Business Analysis : Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices.
• Project Coordination : Assist in planning, tracking, and executing departmental projects and initiatives.
• Stakeholder Communication : Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates.

Required Knowledge and Skills :

Preferred Knowledge and Skills :

Basic Education and Experience :

Preferred Education and Experience :

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Skills Required

Agile Methodologies, System Administration, Project Coordination, Sdlc