Associate Director, RA-CMC PAC DM
$141,500–$268,500 year
HybridNorth Chicago, Illinois, United States
Job Summary
Manage post approval change objectives by independently compiling and authoring chemistry, manufacturing, and control (CMC) sections for marketed product variations. Lead business critical programs through resource management across global initiatives, ensuring CTD content, structural, and formatting requirements are met consistently. Coach and mentor junior staff while driving team reviews with minimal intervention, and provide tactical support to integrate technical issues with regulatory requirements. Identify content gaps and risks for variation documents, develop submission templates, and train the group on regulatory business systems. Support annual reports and renewals with ad hoc baseline assistance. This Associate Director role at AbbVie focuses on immunology, oncology, and neuroscience therapeutic areas.
Required Qualifications
- Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
- Required: 8 years pharmaceutical experience
Desired Qualifications
- Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing, 2-plus years supervising employees
- Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions
- Strong working knowledge of manufacturing unit operations or CTD structure
- Superior oral and written communication skills
- Ability to work cooperatively with all levels and types of global personnel required
- Experience working with electronic document management systems
- Ability to work independently under pressure and manage multiple projects simultaneously
- Detail/accuracy oriented
- Collaborative and willing to learn
- Familiarity with US and other international regulatory requirements for drug product dossiers
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