About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Purpose:

This position ensures that global regulatory CMC dossiers for clinical and marketing applications are created and aligned with current AbbVies CMC best practices. The role works with CMC teams during development of various projects and influences generation of adequate data packages suitable for regulatory submissions. The role collaborates to and authors CTDs to 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 (SME) 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, actively 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, reviews CMC submission documents to ensure content alignment across the submission.

Ensures timely delivery of CMC dossiers to meet regulatory submission timelines, authors regulatory CMC query responses and CMC information for briefing books.

Attends meetings of interactions 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 strong network within department and external stakeholders, utilizes established organizational network to identify opportunities and synergies consistent with project and/or department strategy. Actively mediates team discussions, and facilitates establishment of high performing teams.

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 though contributions to INDs or marketing applications.

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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat 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