Ass. Dir. Regulatory Affairs Functional Initiatives
North Chicago, IL
Location - North Chicago
Industry - Pharmaceutical
The Associate Director Regulatory Affairs Functional Initiatives (ADRAFI) is a key position that leads one or more initiatives to drive increased productivity, compliance, quality, and value across the Regulatory Affairs (RA) organization. ADRAFI needs to serve as a trusted advisor to RA sub-function management for strategy, design and implementation of functional initiatives. ADRAFI will manage large sub-functional or cross-functional initiatives, provide strategic leadership, and demonstrate organizational influence across the RA and associated business, IT, and finance partners. ADRAFI will identify, plan, and execute initiatives that span one or more RA sub-function and related areas. Project initiatives may span regulatory strategy and policy, labeling, advertising & promotion, registration management, submissions operations, CMC and global strategy. Candidates for this position must be able to lead project teams effectively.
Associate Director Regulatory Affairs Functional Initiatives Key Responsibilities Include:
1.Collaborates effectively with; Management, Subject Matter Experts (SMEs), Quality Systems, IT partners, and peers to design cross-functional solutions.
2.Indirectly manages staff; escalates and drives resolution of project issues.
3.Candidate demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.
4.Develops and supports mechanisms to identify, capture, and report business performance metrics.
5.ADRAFI analyzes metrics with subject matter experts in an effort to drive increase compliance, quality, and productivity across the organization.
6.Understands Product Life-Cycle, Business Processes, and Regulations in one or more RA sub-functions.
7.Candidate supports RA management by developing long-term strategies for business performance optimization within RA sub-functions.
8.ADRAFI develops road maps 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.
9.ADRAFI develops project proposals, cost estimates, and schedules leveraging past experience in project management.
10.ADRAFI shepherds proposals to ensure appropriate prioritization within the RA project portfolio and facilitates staffing of initiatives including sourcing of external consultants and service providers.
11.Candidate prepares status reports and dashboards using standard templates and tracks risks, mitigation plans, issues and facilitates resolution, schedules team meetings, establishes agendas, and keeps minutes.
12.Drives continuous improvement, applies concepts of business process mapping, and analysis.
13.Collaborates to develop and document business process maps in accordance with RA standards.
14.ADRAFI works independently to demonstrate organizational influence across RA sub-functions.
15.Transforms concepts into executable initiatives driving the definition of project scopes, schedules and deliverables.
16.Seeks input and forges agreements among sponsors regarding initiative objectives.
17.Candidate frames complex issues for ease of decision-makers.
18.Creates effective management presentations leading to actionable results.
Associate Director Regulatory Affairs Functional Initiatives Required Background:
1.Bachelor's degree in business management, information systems, engineering, math, science or related field
2.At least 7 years' related experience
3.At least 3 years in a leadership role with strong management skills
4.Excellent verbal and written communication skills
5.Able to work with cross-functional teams
6.Need to be able to monitor budget and timelines of projects and resources
7.Manage a budget