Purpose:

This position ensures that global regulatory CMC dossiers for clinical and marketing applications are created and aligned with current AbbVie’s CMC best practices. The role works with CMC teams during development of various projects and influences generation of adequate data packages suitable for regulatory submissions. The role collaborates to and authors CTDs to communicate a single, integrated strategy to health authorities, facilitates timely creation of regulatory CMC query responses and CMC briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content.

Responsibilities

•Embedded in the CMC teams throughout project developments to collaborate on control strategy development and planning of suitable data packages that will support the strategies, provides real-time input on document preparation to ensure a submission-ready data set is generated.

•Actively contributes and/or leads team discussions on CMC topics, actively participates in discussions to develop adequate control strategy and regulatory strategy (story-boarding) as part of the CMC teams.

•Primary author of CMC sections for INDs/IMPDs and BLAs/MAAs to ensure a single, consistent story is communicated to health authorities, reviews CMC submission documents to ensure content alignment across the submission.

•Ensures timely delivery of CMC dossiers to meet regulatory submission timelines, authors regulatory CMC query responses and CMC information for briefing books.

•Attends meetings of interactions with agencies on CMC topics as required, serves as an internal SME for technical topics across the portfolio (e.g., mutagenic impurities, gross content control, etc).

•Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement processes.

•Establishes and maintains strong network within department and external stakeholders, utilizes established organizational network to identify opportunities and synergies consistent with project and/or department strategy. Actively mediates team discussions, and facilitates establishment of high performing teams.