ASSOCIATE DIRECTOR REGULATORY AFFAIRS FUNCTIONAL INITIATIVES
Greator Chicago Area
The Associate Director, RA Functional Initiatives leads one or more initiatives to drive increased productivity, compliance, quality, and value across the Regulatory Affairs organization. Serves as a trusted advisor to RA sub-function management for strategy, design and implementation of functional initiatives. Manages large sub-functional or cross-functional initiatives, provides strategic leadership, and demonstrates organizational influence across RA and associated business, IT, and finance partners.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 teams effectively.
Collaborates effectively with management, Subject Matter Experts (SMEs), Quality Systems, IT partners, and peers to design cross-functional solutions. Indirectly manages staff; escalates and drives 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-cycle, business processes, and regulations in one or more RA sub-functions.Supports RA management by developing long-term strategies for business performance optimization within RA sub-functions. Develops roadmaps and forward-looking planning tools that depict the enablement and evolution of business capabilities to support a given RA sub-function(s), along with the initiatives that will be required to achieve them.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.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.Drives continuous improvement by applying concepts of business process mapping, analysis, and improvement. Collaborates with team members to develop and document business process maps in accordance with RA standards.Works independently in a role that demonstrates organizational influence within or across RA sub-functions and related functions. Transforms concepts into executable initiatives, and drives definition of project scope, schedules and deliverables. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives.Effectively frames complex issues for decision-makers. Prepares and delivers effective management presentations that lead to actionable results.
Bachelors degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field
7+ years related experience
Proven 3 years in a leadership role with strong management skills
Strong verbal and written communication skills
Ability to interact with senior management executives
Ability to work with cross-functional teams
Ability to monitor 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