Senior Director, Regulatory Affairs Business Excellence

About the role

The Senior Director of Regulatory Business Excellence leads a cross-functional team to develop, implement, and improve regulatory business processes across AbbVie. These processes include enhancements in managing existing regulatory information and integrating knowledge and data across the company, particularly within Research and Development (R&D), Regulatory Affairs (RA), and Operations.

Responsibilities

• Lead the regulatory business process team and provide overall vision for developing and implementing more agile regulatory policies and processes that meet current and future business needs.
• Negotiate with business partners on the scope of shared business processes to create overall for one Abbvie processes. 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 so 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 practices.

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.
• 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 processes is preferred.
• Strong interpersonal skills, oral and written communication skills, and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external business partners.
• Ability to direct and lead all aspects of work projects effectively within an environment that has rapidly changing processes, priorities, and deadlines.
• Ability to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders. Creative thinker, motivational leader, strong manager.

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 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.

  AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.

  US & Puerto Rico only - to learn more, visit here.

  To request a reasonable accommodation, US & Puerto Rico applicants can click here.