Assistant Manager, Regulatory Affairs CMC (Global)

The Assistant Manager, Regulatory Affairs Global CMC possesses CMC regulatory knowledge and quality expertise to prepare regulatory assessments and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle. The role involves coordinating CMC activities, ensuring delivery of high-quality components and submissions, managing regulatory issues, and presenting issues for resolution.

Requirements

• Hands-on CMC authoring experience (initial registrations or post-approval variations)
• Solid understanding of the development and commercial activities and cGMP's required to assess technical, scientific and regulatory merits of CMC information, commitments and data
• Updating, interpreting, and applying global and regional CMC guidelines
• Emerging awareness of new scientific or manufacturing technology
• Ability to serve as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

Benefits

• Competitive salaries
• Benefits
• Inclusive environment