Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Location: This position can be located at one of several locations: South San Francisco, CA; Waltham, MA; Worcester, MA; Lake County, IL. 

Job Description

Purpose:

This position participates in global regulatory dossier preparation for AbbVie’s Biologics portfolio activities by gathering information from internal and external partners and authoring elements of global dossiers. The role prepares sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of CMC control strategies. Implement well-defined, efficient processes for preparation of these CMC documents.

Responsibilities

• Authors sections of IND/IMPDs, BLAs/MAAs, and regional requirement documents.
• Gathers and/or authors source information from internal and external partners required to support dossier authoring activities.
• Authors data-rich sections of INDs and MAAs based on current best practices. Authors narrative-rich sections of early-phase INDs.
• Embedded in complex CMC development teams to collaborate on forging CMC control strategies and plan for the data packages that will support the strategies.
• Manage IND/IMPDs dossier submission timelines and supporting activities for early-stage programs.
• Participate in quality checks to ensure the accuracy of dossier content and consults SMEs as needed.
• Contributes to developing automation tools to enhance authoring efficiency.
• Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement pro