FT2E® (Analysis & Design) in the Regulatory Affairs Department of a French Subsidiary - SCALA Management Consulting

International
Pharmaceutical Company

Regulatory Affairs
(France)

appr. 20

Employees

Team SCALA

2

Consultants

Time Period

5

Months

Fast Track to Excellence® (Analysis & Design) in the Regulatory Affairs Department of a French Subsidiary

Starting Point

The Regulatory Affairs department of a French subsidiary in the radiopharmaceuticals sector, which was acquired several years ago, was to be reviewed.
Especially, the service processes, roles and responsibilities, service offerings, work distribution and workload, and country-specific requirements of the four teams of the French Regulatory Affairs department were to be analyzed and solutions for optimization were to be proposed.

Approach

Identifying weaknesses and potential areas for action from the perspective of employees and customers using structured Focus Interviews (23 interviews in total).
Analyzing the top 4 topics “Strategy & Goals,” “Service Processes,” “Organization,” and “Leadership & Management Behavior” with the targeted involvement of employees (tools including brown paper workshops, RACI, joint team meetings, individual interviews).
Analyzing performance figures, cost structures and main cost drivers as well as the employee capacities and workloads.
Developing a to-be concept (including definition of 8 core processes, optimization of the organizational structure, definition of roles & responsibilities, introduction of leadership training and qualification measures for employees) and estimating qualitative and quantitative effects (Benefit Case).
Providing a concrete action plan to realize direct improvement opportunities (“quick wins”) as well as project designs for further more detailed analysis.

Deliverables/Benefits

Overarching strategy and target system for the French unit.
Targeted organizational and communication measures that can be implemented in the short term to increase the quality of results and improve collaboration (“quick wins”).
Project designs for improvemnts in the areas of processes, organization and management skills; expected cost savings: >250 TEUR.

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