Overview

G&L was engaged by a newly appointed Head of Regulatory Affairs (RA) at a large pharmaceutical company.

Tasked with improving efficiency and aligning department activities with strategic goals, the new leader faced challenges in understanding the organization’s culture, workflows, and resource distribution, specifically:

• A need to drive change in a short timeframe, and in a new environment.
• Navigating the new organization: Unfamiliarity with the company’s culture, team dynamics, and internal processes.
• An imposed staggered authority to act – budgetary, human resources (e.g., workers councils), and organization financial cycle restrictions.

Challenges

The new leader shared the following immediate challenges with G&L

• Assessment of organization fit for future purpose: The leader needed data to understand the current operational effectiveness relative to their future vision and to make objective decisions.
• Resource allocation concerns: The department appeared to have many full-time employees (FTEs), but their distribution lacked the requisite evidence to demonstrate the real value to the organization. The leader needed external validation to confirm their notions.
• Siloed ways of working: Distinct mindsets and workstyles across different teams appeared to have created barriers to collaboration and overall performance.

G&L’s Approach and Solution

G&L provided executive-level consulting support to help the Head of RA quickly assess navigate, and overcome their identified challenges and implement strategic improvements. Key activities included:

Rapid department assessment:

• Stakeholder interviews to gather insights into expectations and pain points.
• Process mapping to identify inefficiencies and workflow redundancies.
• Resource audit to evaluate FTE distribution and benchmark alignment with strategic priorities.
• Cultural immersion to understand departmental vocabulary, tools, and best practices.

Roadmap for success:

• Set clear goals aligned with the company’s R&D strategy.
• Foster collaboration by breaking down silos and improving team alignment.
• Optimize resources by redistributing workload, eliminating non-core activities, and addressing bottlenecks.
• Implement quick wins to demonstrate immediate improvements and build momentum.
• Introduce accountability measures through regular progress reviews.

Impact and Outcomes

Rapid onboarding and strategic alignment: The Head of RA gained a clear, data-driven understanding of department activities and challenges within 90 days.
Operational efficiency improvements: The roadmap provided a structured path for optimizing processes and resource allocation.
Empowered functional teams: By involving senior personnel within RA in the identification and options for future improvements, the group became more collaborative, jointly owned success, and improved decision-making. 
Stronger team engagement and leadership credibility: The initiative fostered trust, improved morale, and positioned the leader for long-term success.
Strategic impact: Organizational focus on core activity improved productivity by +15% with a lower overall cost base (+10% savings), achieved through scaling best practice, removing non-value add tasks, and streamlining vendors.
Cross-functional collaboration: A focus on core activity provided a catalyst for leader influence and exposure across company stakeholders, improving the new leader’s standing with the corporation.