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.

The Senior Director Regulatory Portfolio Management is accountable for providing program and project management support across the Regulatory Affairs (RA) organization. This includes project management in support of all Global Regulatory Product Teams (GRPTs), as well as the management of the portfolio of initiatives to drive process improvements and operational efficiencies across Regulatory. As part of the Regulatory Operations Leadership Team, this strategic role drives substantial organizational influence internal and external to RA at the executive level. Liaises with partners and stakeholders to inform, develop, and execute the RA and RQS business strategies. Manages various personnel to include exempt, non-exempt and third party resources.

Responsibilities

• Is accountable for teams of Regulatory Strategic Planners (RSPs) responsible for developing and implementing regulatory strategy and tactics for development and marketed products in support of Global Regulatory Product Teams (GRPTs). Provides guidance to RSPs on operational and procedural leadership and coordination to the GRPT, and drives GRPT operations in support of GRLs.
• Drives the creation and success of an efficient project management team that leads functional RA initiatives supporting the areas, affiliates, and overall RA business; is accountable for the implementation of solutions that lead to agile processes and systems which reduce redundancies to support efficient work across the affiliates globally as well as for centralized functions.
• Oversees the RA project governance framework and processes for initiatives to ensure alignment with business strategy. Ensures the RA Leadership Team is provided with appropriate metrics and reports to effectively manage investments of capital and strategic business change initiatives.
• Drives the creation of short, medium, and long-term plans for regulatory submissions to properly capture, manage, and share key regulatory activities and deliverables while enabling efficient use of Regulatory staff. Creates and sustains an environment that attracts, develops, and retains Regulatory staff to help enhance business relationships, business consulting, project management, and process design skills.
• Leads the vision and execution of strategies and initiatives to effectively manage regulatory information; ensures regulatory information is easily captured and accessed by Regulatory and partner function staff to drive efficient operational activities across Regulatory and its stakeholders.
• Enables process excellence and builds a culture of continuous improvement across RA by providing oversight and mentoring to RA team members that develop and implement process improvement initiatives; effectively drives and manages change throughout the organization.
• Ensures efficient GRPT operations across Regulatory and with our internal partners to effectively plan and execute AbbVie’s Regulatory strategies, along with related continuous improvement initiatives to support the GRPTs.
• Is accountable for efforts related to integration of Regulatory data, systems, and processes related to integration needs related to asset or company acquisitions, licensing, and related initiatives. Collaborates with RA, RQS, and AbbVie-wide groups to manage these initiatives accordingly.
• Demonstrates disciplined project management expertise, effective group facilitation skills, and the ability to drive consensus among team members. Develops innovative and compelling value propositions for proposed initiatives, and effectively frames complex issues for decision-makers.
• Prepares and delivers effective management presentations to AbbVie Leadership, drawing upon personal knowledge of RA business processes, global regulations, and process improvement methods to propose and design innovative business services, systems, and process improvements.

• Required Education:
  - Bachelor’s degree in business management, engineering, science (e.g., biology, chemistry, pharmacy) math, medical, or related field
  - Project Management Institute (PMI) Project Management Professional (PMP) certification
• Preferred Education:
  - Advanced degree in business administration, management, or life sciences-related field preferred
  - Certifications such as RAC from the Regulatory Affairs Professionals Society
  - Lean Six Sigma and/or Organizational Change Management certifications
• Required Experience:
  - 15+ years’ related experience
  - Proven 10 years in a leadership role with strong management skills
  - 8+ years managing people
  - Strong communication skills, both orally and written
  - Strong business acumen and negotiating skills
  - Experience working in a complex and matrix environment
  - Demonstrated ability to lead multi-divisional and multi-functional teams with global aspects
  - Demonstrated ability to manage large teams and functional budgets
• Preferred Experience:
  - 11-13 years in Regulatory Affairs and/or pharmaceutical, healthcare, or regulated industry
  - 10+ years project planning and management including successful implementation of highly complex business initiatives
  - Strong knowledge of pharmaceutical regulations, e.g., FDA and EMA and their impact to organization processes and technology tools
  - Experience interfacing with government regulatory agencies
  -Experience developing and implementing successful regulatory strategies
• - Strong clinical foundation
  - Strong experience working with multiple regulatory functions (Advertising & Promotion, Labeling, CMC, devices, etc.) and cross-functional teams
  - Business/management consulting experience
  - Experience analyzing complex business problems and facilitating the design of innovative solutions. Experience leading and managing functional business area. Experience developing sub-function level business strategies
  -Knowledge of Continuous Improvement/Lean Six Sigma concepts
• Note: Higher education may compensate for years of experience; years of experience may compensate for education

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 short-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 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. 

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