We are seeking a Senior Manager of Regulatory Data Management to help shape and implement our system-based framework. This pivotal role involves building and leading a team focused on delivering global regulatory data management services within the regulatory information management system. The ideal candidate will have advanced knowledge of Veeva Vault RIM and a proven track record of leadership in a data-centric, compliance-driven environment. You will be responsible for fostering a culture of innovation, driving continuous improvement, and ensuring the team meets key operational and compliance standards.
Roles & Responsibilities
- Team Leadership: Build and lead a high-performing, impactful team in AIN, fostering a collaborative and inclusive culture that promotes innovation and continuous improvement. You will develop and implement comprehensive training programs to ensure the team is skilled and knowledgeable.
- Data Governance & Compliance: Establish policies and processes for data usage to minimize potential errors and ensure the team follows all relevant regulations and standards. You will also stay abreast of regulatory developments and ensure the delivery of key operational metrics.
- Operational Excellence: Supervise the provision of high-quality data processing, system utilization, and data management services to global clients. You will drive continuous improvement initiatives to enhance service delivery and operational processes.
- Stakeholder Engagement: Engage with GSIM leadership and cross-functional partners who use the company's Regulatory Information Management system, demonstrating excellence in change management and key customer engagement.
Qualifications
- A Doctorate degree with regulatory systems experience, or a Master's degree with extensive experience, or a Bachelor's degree with significant experience, or a Diploma with a substantial background in regulatory systems.
- Advanced knowledge of Veeva Vault RIM and hands-on ability to work on data-centric processes and systems.
- Proven leadership in regulatory data management, with demonstrated experience in building and leading successful teams.
- Strong knowledge of handling structured and unstructured data.
- Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry is preferred.
- A strong understanding of Regulatory Affairs business complexity and process interdependencies.
