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

About this role

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.


Job Description
Purpose
: This positionparticipatesin global regulatory dossier preparationfor AbbVies Biologics portfolioactivities 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 forpreparation ofthese CMC documents.


Responsibilities

• Authors sections of IND/IMPDs,BLAs/MAAs, and regional requirement documents.
• Gathersand/orauthorssource information from internal and external partnersrequiredto support dossier authoring activities.
• Authors data-rich sections of INDs and MAAs based on currentbest practices.Authors narrative-rich sections of early-phase INDs.
• Embedded in complexCMC developmentteamsto collaborate onforging CMCcontrolstrategiesandplanforthe data packages that will support the strategies.
• ManageIND/IMPDsdossier submissiontimelines andsupportingactivitiesforearly-stage programs
• Participate in quality checks to ensure the accuracy of dossier content andconsultsSMEs as needed.
• Contributes to developing automation tools to enhance authoring efficiency.
• Independentlyidentifiesopportunities for improvement of departmental work processesandcontributes to cross-functional pr...