Associate, Regulatory Affairs Submission Management

Associate, Regulatory Affairs Submission Management Employer AbbVie Location Florham Park, NJ Salary 65500 - 125500 USD Start date May 18, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Company Description 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Associate, Regulatory Affairs Submission Management , manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. The Associate establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications with input from the submission teams. The Associate is recognized as being knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities:

Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables. Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team. Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks Facilitates the creation or procurement of submission content deliverables such as cover letters and forms Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews. Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables. Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software. Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.

Position accountability/scope:

o Supervision required o Receives project assignments from manager but has responsibility for managing own projects with oversight o Reviews project progress with manager on a regular basis with direction provided by manager o May assist with onboarding staff. This position works a hybrid schedule (3 days in office) from the North Chicago, IL or Florham Park, NJ AbbVie headquarters.

Significant Work Activities:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required .

Qualifications Required Education:

Bachelors Degree Required Experience:

Two years pharmaceutical or industry related experience Preferred experience: Publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.

NOTE:

Higher education may compensate for years of experience. Years of experience may also compensate for lower education Additional Information 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 thetimeofthis posting based on the job grade for this position.

Individualcompensation paid within this range will depend on many factors including geographiclocation,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.

Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion 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, visit https://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 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Company info Website http:

//www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert