Join Amgen's Mission of Serving Patients. As a Senior Manager - Regulatory Data Management, you will lead the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners. The role involves shaping and implementing the system-based framework for regulatory data management at Amgen.
Requirements
- 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 follows all relevant regulations and standards.
- 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.
- 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.
Benefits
- Competitive and comprehensive Total Rewards Plans
- Base salary
- Opportunities for professional and personal growth and well-being
