Associate Director, RA CMC

**Associate Director, RA CMC at AbbVie in Waltham, United States** **What you'll do** - Prepare CMC regulatory product strategies and manage regulatory submissions - Analyze and interpret information that impacts regulatory decisions - Develop strategies for CMC agency meetings and manage preparation - Represent CMC regulatory affairs on product development and brand teams **What they're looking for** - Experience in regulatory affairs with focus on Chemistry, Manufacturing and Controls - Strong knowledge of regulatory procedures and changes in regulatory climate - Ability to develop, implement, and document policies and procedures - Experience with regulatory agencies (e.g., FDA) regarding CMC matters **Details** - Location: Waltham, United States - Type: Full-time - Salary: null

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