Aggregate Spend Account Manager-Client Success & Compliance Operations

Overview

We are seeking a dynamic and detail-oriented Aggregate Spend Account Manager specializing in Client Success and Compliance Operations to join our team. This pivotal role focuses on managing and optimizing aggregate spend programs, ensuring compliance with regulatory standards, and fostering strong client relationships. The ideal candidate will possess a deep understanding of pharmaceutical regulatory compliance, clinical trials, and health regulation policies, combined with excellent project management and communication skills. Join us to contribute to advancing healthcare solutions while ensuring rigorous adherence to industry regulations and standards.

Duties

• Lead the development and execution of aggregate spend strategies aligned with FDA regulations, EMA regulations, ICH guidelines, and other relevant health policies.
• Oversee compliance management processes related to pharmaceutical regulatory compliance, biomedical regulatory compliance, and drug regulation to ensure adherence across all client accounts.
• Manage regulatory submissions, including FDA submissions and other international filings, ensuring accuracy and timeliness.
• Conduct comprehensive regulatory compliance analysis to identify risks, gaps, and opportunities for process improvement within client portfolios.
• Collaborate cross-functionally with research teams, quality assurance departments, and project management units to facilitate seamless regulatory compliance projects.
• Utilize compliance management software to track, monitor, and report on regulatory activities and audit readiness.
• Provide expert guidance on chemistry, manufacturing & controls (CMC), regulatory affairs, and quality assurance standards to support client success initiatives.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs or a related field; advanced certifications in regulatory compliance or project management preferred.
• Proven experience working within FDA regulations, clinical trials processes, pharmaceutical regulatory compliance, or biomedical regulatory environments.
• Strong knowledge of ISO 13485 standards, drug regulation policies, EMA regulations, ICH guidelines, and health regulation policies.
• Demonstrated ability in regulatory compliance management software tools and data analysis skills for risk assessment and reporting.
• Excellent writing skills for preparing detailed reports, regulatory documents, and submissions with clarity and precision.
• Experience managing multiple projects simultaneously while maintaining high standards of accuracy and timeliness.
• Effective cross-functional communication skills to coordinate efforts across diverse teams involved in research, quality assurance, legal review, and client success.

Join us in a role that challenges you to ensure the highest standards of regulatory compliance while fostering innovative solutions that impact global health outcomes!

Benefits:

• Paid time off

Work Location: Remote