junior cmc technician.

- Lead and develop innovative global CMC regulatory strategies to ensure optimal development, registration, and lifecycle management of assigned products, balancing business objectives with regulatory compliance.- Serve as the primary CMC regulatory subject matter expert (SME) on global project teams, providing clear, decisive guidance on regulatory risks and requirements.- Interpret and apply global CMC regulations and guidelines (ICH, FDA, EMA, etc.) to all manufacturing and quality-related activities.- Assess the regulatory impact of proposed manufacturing changes (e.g., process changes, site transfers, specification updates) and define the optimal global regulatory filing strategy for timely implementation.- Oversee, author, review, and coordinate the preparation of high-quality CMC sections (Modules 2.3 and 3) for major global regulatory submissions. ...