AbbVie

Manager, Regulatory Affairs Submission Management - Hybrid

AbbVie • $108K — $130K *
North Chicago, IL 60064Hybrid
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree required; relevant experience may compensate for education.
  • 6 years of pharmaceutical or industry experience with publishing software tools.
  • 1-2 years of cross-functional project management experience required.
  • Preferred: PMP and RAC certifications.
  • Background in Regulatory Affairs or related fields such as QA, R&D, or Scientific Affairs.

Responsibilities

  • Independently manage complex submission projects, ensuring timely delivery of high-quality dossiers.
  • Act as the primary interface for Regulatory Affairs submissions, guiding project teams on processes and standards.
  • Plan and lead team meetings, coordinating multiple interrelated submission activities.
  • Coordinate submission publishing with offsite vendors, preparing necessary documentation for publishing.
  • Serve as a Subject Matter Expert, troubleshooting issues and facilitating content deliverables.
  • Conduct detailed quality reviews of published outputs to ensure compliance with regulations.
  • Contribute to process development within the department, implementing improvements and standards.

Benefits

  • Paid time off including vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance.
  • 401(k) plan available for eligible employees.
  • Eligibility for long-term incentive programs.
Full Job Description
The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. The Manager is recognized as a discipline expert and resource in regulatory affairs submission management. Responsibilities:
  • Independently manages high 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 primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverables.
  • Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop 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.
  • May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support. Facilitates the creation or procurement of submission content deliverables such as cover letters and forms. Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
  • Facilitates team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in complex submissions.
  • Actively 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. Creates, implements, and finalizes internal process and standards documents relating to publishing and publishing deliverables.
  • Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions May lead or participate on internal project teams to update business software.
  • Position accountability/scope: o
    • Minimal supervision required o Receives project assignments from manager but has responsibility for managing own projects.
    • Reviews project progress with manager on a regular basis with direction provided on follow-up.
    • Provides estimates of activities with budgetary impact.
    • Trains, mentors and may supervise the work of less experienced staff.
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
  • Required Education: Bachelor's degree.
    • Note: Years of experience may also compensate for lower education.
    • Preferred Education: PMP and RAC certificates a plus
  • Required Experience: 6 years' pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat. One to two years in cross functional project management.
  • Preferred Experience:
    • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
    • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
    • Proven leadership skills and presence
    • NOTE: Higher education may compensate for years of experience.
Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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