Senior Manager - Regulatory Data Management

About the role

Amgen seeks a Senior Manager to lead Regulatory Data Management team within GSIM, driving compliance, process improvement, and digital solutions across global regulatory submissions. Responsibilities include building a high‑performing team, ensuring data accuracy, implementing Veeva Vault RIM, and maintaining regulatory standards. Requires advanced knowledge of Veeva Vault RIM, regulatory systems experience, and proven leadership in data‑centric environments.

What you’ll do

• Build and lead team delivering global regulatory data management services
• Develop inclusive culture promoting innovation & continuous improvement
• Ensure team meets operational metrics & compliance standards
• Drive continuous improvement to enhance service delivery
• Minimize errors by establishing data usage policies & processes
• Supervise high‑quality data processing & system utilisation for global clients
• Develop training programs to upskill team in regulatory data management
• Stay current on regulatory developments & ensure compliance

What you’ll bring

• Doctorate + 2 yrs OR Master + 8‑10 yrs OR Bachelor + 10‑14 yrs OR Diploma + 14‑18 yrs regulatory systems exp
• Advanced knowledge of Veeva Vault RIM
• Proven leadership in regulatory data management
• Hands‑on data‑centric processes and systems
• Strong knowledge of structured & unstructured data
• Excellence in change management & customer engagement

Nice to have

• Experience delivering compliance assurance in large companies
• Experience with large‑scale enterprise systems in Biotech/Pharma
• 5+ yrs regulatory operations & submission management
• Deep understanding of Regulatory Affairs complexity & interdependencies
• Experience with regulatory data across R&D, QA, and related areas
• Proven team building & leadership
• Sharp learning agility & analytical thinking
• Advanced interaction with global key customers

Skills