Senior Manager, Regulatory Affairs Business Operations

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Senior Manager, Regulatory Affairs (RA) Business Operations is responsible for supporting the Regulatory Affairs Leadership team and their direct reports with financial and resource planning cycles including financial plan, long range plan, latest best estimates, and headcount reconciliation. The Senior Manager strategically manages financial plan budget and resource modeling across the functional area in collaboration with the organizational leader, department and R&D finance utilizing knowledge of current and future business environment. This position communicates and presents key information to senior leadership within Regulatory Affairs and influences and strategically manages linkages across the business and understands the impact of business decisions and solutions.

Major Responsibilities:

• Provides forward looking portfolio and resource analyses. Accountable for short- and long-term forecasting of financial and headcount resource needs in various scenarios. Partners with functional area RA leaders and their direct reports in the financial planning process for future initiatives and projects, forecasting and roll-up. Facilitates discussions with functional area head for Long Range Plan, yearly budget cycles and monthly forecasting updates based on latest best estimate.
• Provides leadership and develop strategic recommendations to departments to ensure area operates within the current financial plan/update budget and uses strong business judgement in guiding the leadership team on how to best allocate and leverage funds to meet business needs.
• Leads team meetings to drive resolutions, identify budget risks, and facilitate discussions to drive consensus on change in financial budgeting streamlining.
• Contributes to business resource planning efforts in support of the RA function. Interacts with peers and stakeholders to manage and validate the resource model and drive efficient allocation of resources across the organization. Manages the reconciliation of headcount across the global RA organization.
• Responsible for understanding the regulation and coordinating across Regulatory colleagues to plan for and report status against US filling fees and the reconciliation of the annual FDA PDUFA invoice.
• Responsible for completing cross functional projects and strategic initiatives related to Business Operations deliverables. Gains buy-in from management and other appropriate parties.
• Manages budget Ready to Go and Ready to Give Up process to support the effective use of RA and RDQA budgets including intake, tracking, communication, end of year summary, and reconciliation with Finance on Ready to Go items. Provides leadership as business process owner for the RA and RDQA budget Ready to Go process including the creation of process flow diagrams depicting activities. Contributes to the identification of gaps and may be assigned to lead change efforts to current process with a focus on continuous improvement.
• Maintains a strong working knowledge of the RA function evolution, business operations, products and services of RA to effectively communicate, interact and influence key internal stakeholder groups on behalf of RA.
• Demonstrates expertise in utilizing multiple systems/software tools (SRM, Excel, SharePoint) to capture, read analyze and report pertinent financial and resource modeling data. Collaborates with Finance on developing financial tracking and summary standards.
• Acts with demonstrated ability to analyze issues and opportunities, foster innovation and the development of creative mechanisms for solving business issues, and plan/oversee effective implementation of projects and/or initiatives related to resource modeling, Ready to go/give up, LRP, functional/capital plan, and monthly financial cycle. Gains buy-in from management and other appropriate parties.

Qualifications

• Bachelor's degree required. Advanced degree preferred. Certification a plus.
• Minimum 7 years related experience required. 5 years pharma, health care or industry related experience preferred. 5 years' experience in a business operations role; and/or experience in finance/accounting/procurement preferred. Knowledge of pharmaceutical regulations, i.e. FDA and European Union and their impact to organization processes and technology tools preferred.
• Strong communication skills, both verbal and written
• Experience in managing functional budgets and developing budget forecasts
• Strong business acumen and effective negotiation skills
• Experience working in a complex and matrix environment
• Demonstrated ability to craft compelling business cases that prompt appropriate action.
• 3+ years of work experience in the area supported (e.g. Discovery, Development) and 6+ years in pharmaceutical, healthcare or regulated industry preferred.
• Proven track record of developing and executing change management strategies or successful project planning and management of highly complex business and technology initiatives is preferred.
• Note: Higher education may compensate for years of experience

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.