Associate Director, CMC Regulatory Affairs

Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program.

Requirements

• Lead regulatory CMC strategy and execution for assigned development programs
• Provide regulatory and scientific expertise to shape CMC strategies for development programs
• Collaborate cross-functionally with technical and regulatory teams to support product development and lifecycle management
• Oversee preparation, review and submission of high-quality CMC sections for investigational and registration submission
• Develop strategies and lead teams in the preparation of key CMC related Health Authority meetings
• Foster relationships and proactively communicating with key stakeholders
• Develop and implement best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations

Benefits

• Hybrid workplace model
• Compliance with global regulatory standards
• Alignment with internal program goals