Senior Director, Regulatory Portfolio Management

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 m...