Manager / Senior Manager, CMC Dossier Strategy and Leadership

Role Summary

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 projects.
• Establish and maintain strong networks within departments and external stakeholders. Utilize an established organizational network to identify opportunities, gaps and synergies consistent to improve efficiency within role.

Qualifications

• Manager: Bachelors with 8, Masters with 6, or PhD with 3 years of CMC biologics functional experience.
• Senior Manager: Bachelors with 10, Masters with 8, or PhD with 5 years of CMC biologics functional experience.
• Prior experience in a relevant laboratory conducting development work, preferably including through contributions to INDs or marketing applications.
• Appropriate level of understanding of ICH guidance for CMC control strategies.