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Senior Regulatory Affairs Associate - Clinical Research

Baylor College of Medicine • Houston, TX, US • published 2026-11-12 07:00:05.009679

Description

**Summary** ----------- Primarily manages regulatory portfolios or clinical research protocols of high complexity, under minimal supervision. Develops and implements regulatory strategies, ensures compliance, and facilitates product development and approvals. Acts as a key liaison with investigators, sponsors, government agencies, and IRBs, providing expert guidance and handling intricate regulatory submissions and reporting. This is a very fast paced role working with many moving parts which could include submissions to several different institutions. After initial training period this role may be eligible for a hybrid work schedule. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay. **Job Duties** -------------- * Serves as not only the primary individual responsible for obtaining regulatory approvals but also as the project manager responsible for overall project readiness and protocol implementation. * Collaborate with cross\-functional teams to ensure regulatory compliance and successful product development. * Create, collate and confirmsthe content of all submission...

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