Manager, Regulatory Strategic Planning

Lake County, IL, US
Apr 12, 2019
Required Education
Bachelors Degree
Position Type
Full time
  • Identifies, plans, and executes initiatives across one or more RA sub-functions and related areas. Initiatives may span regulatory strategy and policy, regulatory content management, labeling, advertising & promotion, registration management, area & affiliate operations, and/or submissions operations.
  • Develops project proposals, cost estimates, and schedules leveraging past experience in project management. Shepherds proposals to ensure appropriate prioritization within the RA project portfolio. Facilitates staffing of initiatives including sourcing of external consultants and service providers.
  • Contributes to business planning efforts in support of the Regulatory Affairs function. Interacts with peers and stakeholders to drive efficient allocation of resources across related and partner functions such as IT, finance, and related business areas.
  • Leads project team meetings effectively; uses the project governance process to effectively escalate and drive resolution of project issues; demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.
  • Possesses a working knowledge of product life-cycle, business processes and regulations in one or more RA sub-functions.
  • Develops effective working relationships with team members; communicates and interacts effectively with project sponsors, and shares information regarding projects concisely and effectively to project stakeholders.
  • Helps implement a project management approach for initiatives; develops project plans in support of the project management approach.
  • Prepares status reports and dashboards using standard templates. Tracks risks and mitigation plans; tracks issues and facilitates resolution; schedules team meetings; establishes agendas, keeps minutes.
  • Facilitates business teams to develop current state and future state process models.
  • Coordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools .

  • Required Education: Bachelor's degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field
  • Preferred Education: Advanced degree in business administration, information systems, or life sciences-related field preferred Project Management Institute (PMI) Project Management Professional (PMP) certification preferred, especially for initiative managers responsible for leading functional and capital efforts
  • Required Experience: 7 years' related experience Proven leadership skills and presence Strong communication skills, both orally and written Experience working in a complex and matrix environment
  • Preferred Experience: 3 years in pharma, health care or regulatory experience proficient in project planning and management including successful implementation of highly complex business and/or technology initiatives Experience facilitating process modeling and redesign initiatives Training and/or experience with process modeling tools
  • Experience serving as a business management consultant Knowledge of Continuous Improvement/Lean Six Sigma concepts
  • Note: Higher education may compensate for years of experienc e