Assessing Core Business Processes of a Regulatory Affairs Function

Client Background:
Regulatory Affairs Department of leading pharmaceutical company

Challenge:
Department’s core processes were manual and paper-intensive, and its organizational structure was not optimized, leading to decreased employee productivity, errors and increased risk of missing regulatory filing deadlines

Solution:
TA consultants worked with senior management to isolate and address leadership concerns and shortcomings in management, communication, planning, prioritization, and processes standardization. The Regulatory function was then restructured into three distinct functions: Therapeutic Areas, Intelligence, and Regulatory Operations. TA consultants then redefined roles, responsibilities and performance expectations and created career paths for all team members. Finally, the team attended a suite of management development programs designed to address observed issues. The function also engaged TA coaches in 1-on-1 leadership coaching with key members of the leadership team.

Impact:
Findings were communicated at strategic planning session and changes implemented in partnership with department team members. Individual and team performance improved dramatically. Employee satisfaction measures became more positive, and retention of key personnel improved.

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