Senior Manager - Regulatory Data Management

About the role

The Global Submission and Information Management (GSIM) team provides strategic technical expertise for Amgen's global regulatory submissions and information management, ensuring compliant data flows between internal areas, external partners and regulators. The Senior Manager of Regulatory Data Management helps shape and implement the system-based framework for regulatory data management, leads the Data Management team in AIN, works with GSIM leadership and cross-functional partners using the Regulatory Information Management system, and builds and leads the team from the ground up.

Key responsibilities

• Build and lead a team delivering global regulatory data management services within the regulatory information management system, with a collaborative and inclusive culture.
• Ensure the team meets operational metrics and compliance standards, with high accuracy and efficiency.
• Drive continuous improvement of service delivery and processes, and establish policies and processes for data usage to minimise errors.
• Supervise high-quality data processing, system use and data management services for global clients.
• Develop and run training programmes for team members.
• Stay up to date with regulatory developments and ensure the team follows all relevant regulations and standards.

Required profile

• One of: doctorate with 2 years of regulatory systems experience, master's with 8-10 years, bachelor's with 10-14 years, or diploma with 14-18 years of regulatory systems experience.
• Proven leadership in regulatory data management and hands-on work on data-centric processes and systems.
• Strong knowledge of structured and unstructured data, and demonstrated excellence in change management and customer engagement.
• Preferred: compliance assurance experience in a large company, large-scale enterprise systems in biotech/pharma, 5 years in regulatory operations/submission management, regulatory affairs experience, and experience building and leading teams.

Required skills

• Advanced knowledge of Veeva Vault RIM
• Regulatory data management

Amgen states it offers a competitive total rewards package including benefits and a base salary, and applies an equal opportunity policy.