Associate Director GRAAS Operations

In this vital role you will drive operational excellence, innovation, and technical compliance for Amgen's global regulatory submission and information management.

Ensures smooth, compliant data flows among functional areas, external partners, and regulatory authorities while designing and implementing process improvements, digital technologies, data standards, and organizational change management to achieve business results.

The Global Submission and Information Management Associate Director will help shape and execute the strategic framework for regulatory submissions and systems.

This leadership role ensures compliance and operational excellence by integrating tactical execution across global submission portfolios and regulatory systems in harmonization with strategic vision.

The role involves leading the GSIM team in AIN, engaging with GSIM leadership, vendor partners and cross-functionally, ensuring adherence to evolving regulatory requirements, and continuously innovating processes, systems, and data standards.

Roles & Responsibilities:

• Manage and mentor a high-performing AIN team responsible for submissions, data management and regulatory systems.
• Develop and implement resourcing strategies, leveraging internal teams and external partners for submission-related activities in the AIN context.
• Drive process improvements for submission tools, methodologies, and workflows.
• Oversee vendor collaborations to enhance system capabilities and influence product roadmaps.
• Ensure staff understanding and adherence to global and regional regulatory guidelines.
• Help to ensure regulatory information and systems meet global compliance and data security standards.
• Maintain and optimize data models, including IDMP, SPL, and other regulatory standards.
• Help to develop and implement policies, SOPs, training materials, and guidelines for regulatory practices.
• Champion innovation within regulatory technologies and submission processes to drive efficiency and maintain industry leadership. Integrate trends, data, and information into plans, results, and recommendations.
• Integrate business needs and evolving regulatory landscapes into system updates and process enhancements.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree and 3 years of of experience in regulatory submissions or systems OR
• Masters degree and 10 to 14 years of experience OR
• Bachelors degree and 14 to 16 years of experience OR
• Diploma and 18 to 20 years of experience

Preferred Knowledge and Skills:

• Proven leadership in submissions and regulatory information management.
• Advanced knowledge of global and regional regulatory requirements for submissions, including eCTD and related software.
• Expertise in regulatory information management systems (RIMS), data models (IDMP, SPL), and system simplifications.
• Strong project/program management skills and the ability to manage cross-functional teams.
• Effective collaboration and communication skills with internal/external collaborators and regulatory authorities.
• Analytical and problem-solving skills to address complex regulatory and systems issues.
• Experience with global regulatory submission delivery
• Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry.
• Experience in regulatory operations, submission management, or information systems.