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Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs

jobgether

USdirectorFull-time
Posted
today
Source
Jobgether (lever)

Skills

LeadershipNext.js

Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs based in the United States. The Director will lead the US CMC Regulatory Affairs team while shaping global regulatory strategies for veterinary pharmaceutical products across development, approval, and commercial lifecycle management. This senior leadership role combines team management, regulatory expertise, and innovation to ensure compliance with FDA requirements and applicable international regulations. The successful candidate will oversee post-approval changes, manufacturing and technology transfers, product improvements, and regulatory initiatives that support supply chain continuity and operational excellence. In parallel, the Director will guide global CMC innovation strategies for small-molecule products, supporting pipeline development, registration preparation, and market authorization across major regions. Working closely with development, manufacturing, quality, clinical, supply chain, and external manufacturing partners, the role ensures regulatory plans align with scientific, quality, and business priorities. This is an opportunity to influence global regulatory practices, develop high-performing teams, and help advance innovative veterinary medicines in a fully remote environment.

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Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs at jobgether · JobMatch