Senior Director, Regulatory Excellence & Process Innovation

Regulatory Jobs; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie in North Chicago is seeking a Senior Director of Regulatory Business Excellence to lead a cross-functional team of business process owners and to develop, implement, and improve regulatory processes across RA, R&D, and operations.

This role emphasizes agile policies, continuous improvement, training, change management, and knowledge management, with responsibility for key submission support programs and performance metrics.

Qualifications

• Bachelor’s degree in science such as chemistry, biology, or pharmacy, business or related field.
• Advanced degree in science or business, such as MS, PhD, PharmD, MBA.
• Fifteen years of relevant experience including eight years in leadership positions withpeopleleader responsibilities.
• This role requires excellent writing and presenting skills.

Responsibilities

• Lead the regulatory business process team and provide overall vision to developingandimplementingmore agile regulatory policies and processesthat meet current and future business needs.
• Negotiate with business partners on scope of shared business processes tocreate overallall for oneAbbvie processes.With businesspartnersdevelop mechanisms to measure process health.
• Lead teams responsible for key submission support programs,playbooksand tools, such as Global Submission Support Center, and E2E Submission Excellence. Develop and track metrics to measure progress.
• Leadteams responsible forkey capabilities supporting the business, including Change Management, Training andCollaborativeand Visual Design services.
• Establish a Continuous Improvementmethodologythat includes tools and processes to be shared with Abbvie Regulatory Affairs colleagues such that they develop key skills and attributes they need to be successful.Partner with stakeholders in RA to develop and deliverappropriate training, communications, project/change management, and success measures.
• Lead activities with Quality Assurance and internal SMEs to address exceptions, issue investigations, change plans, and inspection responses related to RA processes.
• Engage in external benchmarking and advocacy with regulatory agencies and external organizations to ensure efficacy, compliance, and competitive advantage of Abbvie processes. Partner with peers within Regulatory Affairs to share findings and influence change.
• Manage complex projects to ensure adherence to appropriate regulatory requirements and current industry bestpractice.

Skills

Leadership experience

Written & verbal communication

Stakeholder management

Education

Bachelor’s degree in science (chemistry, biology, or pharmacy, business or related field)

Advanced degree in science or business (MS, PhD, PharmD, MBA)

Job description

AbbVie in North Chicago is seeking a Senior Director of Regulatory Business Excellence to lead a cross-functional team of business process owners and to develop, implement, and improve regulatory processes across RA, R&D, and operations.

This role emphasizes agile policies, continuous improvement, training, change management, and knowledge management, with responsibility for key submission support programs and performance metrics.