Associate Director, RA CMC

Role: Associate Director of Regulatory Affairs for CMC at AbbVie, overseeing regulatory strategy and submissions for pharmaceutical products. Responsibilities include developing and managing content strategies for INDs, CTAs, marketing applications, and variations; preparing and reviewing regulatory submissions; liaising with agencies like the FDA; and representing CMC on cross-functional teams. The role entails negotiating, influencing, and advising to facilitate first-pass approvals, managing change controls, and staying current with regulatory updates. It also involves policy development, internal initiatives, and mentorship. Qualifications: Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related field; 8+ years of pharma experience with at least 3 years in a leadership role; experience in global regulatory strategy, agency interaction, and working within complex matrix environments. Preferred: advanced degree and certifications; 10+ years in pharma, including R&D or manufacturing. High-Value: expertise in CMC regulatory processes, global regulatory strategy, and agency negotiations; experience with biologics or small molecules is implied. Collaboration includes internal R&D, Operations, and Regulatory teams, with external agency interactions. Location: Not specified; likely corporate or remote. Travel: Not specified.