Senior Director, Regulatory Affairs Business Excellence

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 Senior Director of Regulatory Business Excellence is accountable to lead a cross functional team of Business Process Owners as they develop, implement, and improve regulatory business processes across Abbvie. These business processes include improvements in how we manage existing regulatory information, and how we integrate knowledge and data across AbbVie, especially within R&D, RA, and Operations. The Senior Director will have a leading role in ensuring continued success of ongoing key submission support programs as well as ensuring RA business processes support future business needs, including AI enablement and knowledge management. This role is also accountable for building and maintaining key capabilities critical for business process success in RA, such as Training, Change Management, and Collaborative and Visual Design Services.  

Responsibilities

• Lead the regulatory business process team and provide overall vision to developing and implementing more agile regulatory policies and processes that meet current and future business needs. 

• Negotiate with business partners on scope of shared business processes to create overall all for one Abbvie processes. With business partners develop mechanisms to measure process health. 

• Lead teams responsible for key submission support programs, playbooks and tools, such as Global Submission Support Center, and E2E Submission Excellence. Develop and track metrics to measure progress. 

• Lead teams responsible for key capabilities supporting the business, including Change Management, Training and Collaborative and Visual Design services.  

• Establish a Continuous Improvement methodology that 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 deliver appropriate 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 best practice. 

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 with people leader responsibilities. Experience should come from pharmaceutical development and commercialization with a wide background of responsibilities in regulatory, R&D, quality, manufacturing, or laboratory. 

• This role requires excellent writing and presenting skills. 

•  Preferred Experience 

• A solid business process management and improvement background is key. The applicant should demonstrate this background with a combination of examples of improved business processes and training such as six sigma, or experience with Business Process Owner frameworks, process optimization/simplification, process KPI establishment and measurement. 

• Experience in change management, training and quality as applied to business process is preferred.  

• Strong interpersonal skills, oral and written communication skills, and ability to work effe