This position will support global CMC regulatory activities related to investigational/commercial drug and biologic products. This position will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for preparation of global CMC regulatory submissions

Accountable for strategy, planning, definition of content, and preparation of global regulatory eCTD CMC submissions and responses to Health Authority questions

• Identifies supporting documents required for global CMC submissions
• Prepares CMC briefing documents for meetings with regulatory agencies
• Participates in CMC meetings with regulatory agencies
• Directs CMC activities associated with global regulatory registration of drug and biologic products
• Provides CMC regulatory guidance and support to project core teams
• Provides CMC strategic support to investigational and commercial products
• Reviews CMC submission documents relative to regulatory guidance requirements