Senior Director, Regulatory Affairs Business Excellence
AbbVie
July 02, 2026
Remote friendly (North Chicago, IL)
United States
$206,500 - $393,000 USD yearly
Corporate Functions
Responsibilities:
- Lead cross-functional regulatory business process team; develop and implement agile regulatory policies/processes.
- Negotiate with business partners on shared regulatory business processes; define mechanisms to measure process health.
- Lead key submission support programs (e.g., Global Submission Support Center, E2E Submission Excellence); develop and track progress metrics.
- Lead capabilities supporting the business, including Change Management, Training, and Collaborative/Visual Design services.
- Establish Continuous Improvement methodology and share tools/processes with Regulatory Affairs; partner to deliver training, communications, change management, and success measures.
- Partner with Quality Assurance and internal SMEs to address exceptions, issue investigations, change plans, and inspection responses.
- Conduct external benchmarking/advocacy with regulatory agencies and external organizations; share findings with Regulatory Affairs peers to influence change.
- Manage complex projects to ensure regulatory compliance and adherence to industry best practices.
Qualifications:
- Bachelor’s degree in science (chemistry, biology, pharmacy) or business/related field.
- Advanced degree (MS, PhD, PharmD, MBA) in science or business.
- 15 years relevant experience; 8 years in leadership with people-leader responsibilities; experience across pharmaceutical development/commercialization and regulatory, R&D, quality, manufacturing, or laboratory.
- Excellent writing and presenting skills.
- Preferred: business process management/improvement (e.g., Six Sigma, Business Process Owner frameworks, process optimization/simplification, KPI establishment/measurement); experience in change management/training/quality applied to business processes.
- Strong interpersonal skills and communication; ability to influence cross-functional/internal/external partners; lead in fast-changing environments; prioritize multiple tasks; creative, motivational leader.
Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k) eligible employees; eligible for long-term incentive programs.
- Lead cross-functional regulatory business process team; develop and implement agile regulatory policies/processes.
- Negotiate with business partners on shared regulatory business processes; define mechanisms to measure process health.
- Lead key submission support programs (e.g., Global Submission Support Center, E2E Submission Excellence); develop and track progress metrics.
- Lead capabilities supporting the business, including Change Management, Training, and Collaborative/Visual Design services.
- Establish Continuous Improvement methodology and share tools/processes with Regulatory Affairs; partner to deliver training, communications, change management, and success measures.
- Partner with Quality Assurance and internal SMEs to address exceptions, issue investigations, change plans, and inspection responses.
- Conduct external benchmarking/advocacy with regulatory agencies and external organizations; share findings with Regulatory Affairs peers to influence change.
- Manage complex projects to ensure regulatory compliance and adherence to industry best practices.
Qualifications:
- Bachelor’s degree in science (chemistry, biology, pharmacy) or business/related field.
- Advanced degree (MS, PhD, PharmD, MBA) in science or business.
- 15 years relevant experience; 8 years in leadership with people-leader responsibilities; experience across pharmaceutical development/commercialization and regulatory, R&D, quality, manufacturing, or laboratory.
- Excellent writing and presenting skills.
- Preferred: business process management/improvement (e.g., Six Sigma, Business Process Owner frameworks, process optimization/simplification, KPI establishment/measurement); experience in change management/training/quality applied to business processes.
- Strong interpersonal skills and communication; ability to influence cross-functional/internal/external partners; lead in fast-changing environments; prioritize multiple tasks; creative, motivational leader.
Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k) eligible employees; eligible for long-term incentive programs.