Manager, Regulatory Affairs
Geography: Greater Chicago Area
Compensation: Competitive salary and bonus
Contact: Ken Kupersmith firstname.lastname@example.org
"Identifies, plans, and executes initiatives across one or more RA sub-functions and related areas. Initiatives may span regulatory strategy and policy, labeling, advertising & promotion, registration management, submissions operations, CMC and/or global strategy..
"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.
"Develops and 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.
"Possesses a working knowledge of product life-cyle, 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.
"Bachelor's degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field
"7 years' related experience
"Proven leadership skills and presence
"Strong communication skills, both orally and written
"Experience working in a complex and matrix environment
"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
"3 years in pharmaceutical, healthcare or regulated industry
"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