Manager, Regulatory Strategic Planning

The Manager Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for cross-functional teams of low- to medium-complexity within and across the Regulatory Affairs organization. The individual combines knowledge of scientific regulatory and business processes to properly drive the execution of AbbVies regulatory strategies. Responsibilities include developing and managing the schedules activities and deliverables for the Global Regulatory Product Teams (GRPTs) interacting with key stakeholders and leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity.

Responsibilities:

• Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory milestones are adequately planned and tracked and works with Regulatory staff across the globe to drive the execution of GRPT-related activities and deliverables.
• Plans and facilitates GRPT and related meetings (e.g. Dossier Kick-off Meetings Regulatory Strategic Reviews Rapid Response Teams and Regulatory Advisory Panels); ensures action items are assigned and completed; periodically summarizes and shares team highlights with stakeholders as necessary.
• Interacts with ADTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program.
• Drives GRPT operations in support of the Global Regulatory Lead (GRL); ensures GRPT-related information and tools (e.g. team sites rosters charters schedules) are kept up to date.
• Executes process improvement initiatives of low- to medium-complexity; is able to move ideas from concept to implementation.
• Possesses proficient knowledge of the regulatory product lifecycle business processes and regulations across Regulatory sub-functions; is able to provide business subject matter knowledge on assigned initiatives and demonstrates effective problem solving & decision making learning and adjusting behaviors based on prior results/experience.
• Leads team meetings effectively; uses the project governance process to effectively escalate and drive resolution of issues; demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes. Develops effective working relationships with project team members; prepares and delivers clear relevant and influential written reports and presentations for a variety of audiences.
• Coordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools; manages and tracks budgets contracts communications metrics and reporting-related processes.
• Supports mechanisms to identify capture and report business performance metrics. Analyzes metrics with subject matter experts in an effort to drive increase compliance quality and productivity across the organization.
• Incorporates diverse cross-functional and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.
• This position will work a hybrid work schedule (3 days in office) from the AbbVie Lake County IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications :

• Required Education:
  Bachelors degree in science (biology chemistry microbiology medical technology pharmacy pharmacology) math engineering business management or medical field
• Preferred Education:
  - Advanced degree in science math business management or engineering is preferred
  - Certifications such as RAC from the Regulatory Affairs Professionals Society and/or Project Management Institute (PMI) Project Management Professional (PMP) are preferred
• Required Experience:
  - 5 years related experience. Proven leadership skills and presence. Experience working in a complex and matrix addition with 3-5 years in pharmaceutical healthcare or regulated industry preferred. Strong verbal and written communication skills.
  - Ability to interact with senior management and executives. Ability to work with cross-functional teams. Ability to manage budget and timelines of projects and resources within a program or department. Ability to manage a budget and forecast financial requirements
• - Strong attention to detail and problem solving skills
  - Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks
  - Keen awareness to cultural nuances; proven ability to work in a global environment
  - Ability to successfully interact with multi-divisional and multi-functional teams from across the globe
• Note: Higher education may compensate for years of experience; years of experience may compensate for education

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 that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

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Work :

No

Employment Type :

Full-time