Senior Manager CMC Dossier Strategy and Leadership

Role Summary

This role ensures global regulatory CMC dossiers for clinical and marketing applications are created and aligned with AbbVie’s CMC best practices. It works with CMC teams during development to generate adequate data packages for regulatory submissions, collaborates to author CTDs that 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 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, 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, and reviews CMC submission documents to ensure content alignment across the submission.
• Ensures timely delivery of CMC dossiers to meet regulatory submission timelines, and authors regulatory CMC query responses and CMC information for briefing books.
• Attends meetings 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 a strong network within the department and external stakeholders, uses the network to identify opportunities and synergies consistent with project and/or department strategy; mediates team discussions and facilitates the establishment of high-performing teams.

Qualifications

• Required: Bachelor with 10, Master with 8, or PhD with 5 years of CMC functional experience including late-stage development experience
• Preferred: Prior experience in a relevant CMC function (e.g., analytical, formulation, process, device/combination product development, etc) translating experimental work into at-scale drug substance or drug product manufacturing.
• Technical writing experience communicating experimental development work, preferably including contributions to INDs or marketing applications.