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.

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 process improvement projects.
• Establish andmaintainstrongnetworkswithindepartmentsand external stakeholders. Utilizean establishedorganizational network toidentifyopportunities,gapsand synergies consistent to improve efficiency withinrole.

• Manager:Bachelors with 8,Masterswith 6, or PhD with 3 years of CMCbiologicsfunctional experience.
• SeniorManager:Bachelors with 10,Masterswith 8, or PhD with 5 years of CMCbiologicsfunctional experience.
• Prior experience in a relevant laboratory conductingprocess developmentthat leads tobiologicsdrug substance and/or drug productcommercial manufacturing processes, preferably including through contributions to INDs or marketing applications.
• Experience withCMC controlstrategyforbiologicswhichalignswithICHqualityguidance.
• Experienceauthoring phase-appropriate Module 3 for IND/IMPD and BLA/MAA.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Name: AbbVie
Website: https://careers.abbvie.com/en/job/m...
Company Description:

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