Senior Regulatory Affairs Specialist PRN (Remote)

Pace Labs • Remote, US • published 2026-09-22 04:42:22.033373

Description

Shift: Monday through Friday, 8:00AM \- 5:00PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. Lead and execute global regulatory strategies to ensure our client’s investigational, new, and marketed products are developed and maintained in compliance with global regulatory requirements. Serve as a strategic advisor to clients, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes. Compensation: $85\.00 per hour **Key Responsibilities:** * Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. * Documentation: Draft and maintain high\-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols. * Communication: Support regulatory interactions by preparing responses to CMC\-related questions from FDA, EMA, PMDA, and other global health authorities. * Strategy Implementation: Prepare and Lead Regulatory interactions for...

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