regulatory affairs specialist.

Key Responsibilities: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. ...