Senior Manager - Regulatory Data and Analytics

What you will do

The Global Submission and Information Management (GSIM) team brings strategic technical expertise to 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.

• Build and lead a successful team, focused on delivering global regulatory data analytics services across processes and systems.
• Ensure compliance with international data standards to ensure compliance with Health Authority regulations for submission and registration.
• Collaborate cross-functionally internally and externally with Global Regulatory Affairs and Strategy (GRAAS) to identify Regulatory Data and Analytics requirements.
• Lead Strategy development and implementation for new and existing Regulatory Data Standards, Analytics, and Reporting.
• Partner with Digital Technology and Innovation (DTI) Team to develop multi- year Data Standards, Management, and Analytics to increase Regulatory Data Visibility and insights.
• Increase data insight to make it easier for leadership to quickly and confidently find the right data for their business decisions.
• Set standards to scale data and usage with repeatable processes to keep (meta) data up to date.
• Leverage global regulations to support system and process simplification, automation and innovation.
• Organize and present data in user friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance.

What we expect of you

The Senior Manager of Regulatory Data and Analytics will help shape Amgens strategic approach towards Regulatory Affairs analytics, Data Standards and emerging Data Standard compliance. The role involves leading the Data and Analytics team in AIN, engaging with GSIM leadership and cross-functional partners who use Regulatory and Master data across processes and systems. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key analytics and reporting.

Basic Qualifications:

• Doctorate degree and 2 years of regulatory systems experience OR
• Masters degree and 8 to 10 years of regulatory systems experience OR
• Bachelors degree and 10 to 14 years of regulatory systems experience OR
• Associates degree and 14 to 18 years of regulatory systems experience OR
• Advanced knowledge of Veeva Vault
• Proven leadership in regulatory data and analytics and reporting
• Proven experience of devising data-centric processes and systems.
• Strong Knowledge of handling structured and unstructured data
• Demonstrated excellence in change management and key customer engagement.

Preferred Qualifications:

• 5+ years of proven experience in Regulatory Affairs.
• Experience with delivering data strategy across a large enterprise
• Ability to build compelling cases with accurate cost and effort estimations
• Excellent understanding of IDMP, Regulatory Affairs business complexity and process interdependencies
• Experience with regulatory master data in Regulatory Affairs, Research, Development, Quality Management, or related area.
• Demonstrated experience in building and leading successful teams.
• Sharp learning agility and analytical thinking
• Proficiency in data visualization tools or packages, such as Tableau or Spotfire.
• Proven and advanced interaction with global partners