Senior Manager - Regulatory Data Management

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.

The Senior Manager of Regulatory Data Management will help shape and implement the system based framework for regulatory data management at Amgen.

The role involves leading the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners who use the company Regulatory Information Management system. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance.

• Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system.
• Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement.
• Ensure the team meets key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency.
• Drive continuous improvement initiatives to enhance service delivery and operational processes.
• Minimize potential errors by establishing policies & processes for data usage.
• Supervise the provision of high-quality data processing, system utilisation and data management services to global clients.
• Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices.
• Stay abreast of regulatory developments and ensure the team is follows all relevant regulations and standards.

What we expect of you

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
• Diploma and 14 to 18 years of regulatory systems experience OR
• Advanced knowledge of Veeva Vault RIM
• Proven leadership in regulatory data management
• Hands-on ability to work on data-centric processes and systems.
• Strong Knowledge of handling structured and unstructured data
• Demonstrated excellence in change management and key customer engagement.

Preferred Qualifications:

• Experience with delivering compliance assurance within a large company
• Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry.
• 5 years of proven experience in regulatory operations, submission management.
• Excellent understanding of Regulatory Affairs business complexity and process interdependencies
• Experience with regulatory 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
• Proven and advanced interaction with global key customers.