AbbVie

Senior Manager, Regulatory Affairs Process Excellence

AbbVie • $120K — $145K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences; advanced degree preferred
  • 8+ years of experience in regulatory, pharmaceutical, or device sectors
  • Experience in Regulatory Affairs, Quality, or process excellence roles
  • Proficient in managing issue/CAPA systems and exception reporting
  • Familiarity with audit and inspection readiness in regulated environments
  • Strong organizational, analytical, and communication skills
  • Ability to influence in a matrixed environment and manage multiple priorities

Responsibilities

  • Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) for issue tracking and resolution
  • Triage RAIM issue records to assess severity and determine next steps
  • Escalate issues to Exception Reports based on risk and compliance impact
  • Project manage Exception Reports with cross-functional teams to drive corrective actions
  • Collaborate with various stakeholders to ensure timely and effective issue management
  • Support internal and external audits, including documentation coordination and follow-up
  • Manage legacy company integrations through change plans in OneTrack

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
  • Eligibility for long-term incentive programs
  • Hybrid work schedule (3 days in office, 2 days remote)
Full Job Description
Job Description

The Senior Manager, Process Excellence within Regulatory Affairs, is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.

Responsibilities:
  • Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved
  • Triage RAIM issue records to determine severity, impact, and appropriate next steps
  • Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance
  • Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processes
  • Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective
  • May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed
  • Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
  • Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations
  • Partner with stakeholders to support effective communication, implementation, and adoption of process changes.
  • This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL 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: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plus
  • Required Experience: 8+ years of regulatory, pharmaceutical or device experience.
  • Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
  • Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows
  • Experience supporting audit and inspection readiness in a regulated environment
  • Strong organizational, analytical, communication, facilitation, and stakeholder management skills
  • Ability to manage multiple priorities and work effectively across functions and levels
  • Ability to influence without direct authority and work in a matrixed environment


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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