The Challenge:

 

A global pharmaceutical company was undergoing a major operational shift, transitioning several key regulatory activities to a new strategic partner. To lead this complex change, the organisation required a consultant with deep expertise in regulatory affairs, vendor management, and project delivery—someone who could manage multiple stakeholders, mitigate risks, and ensure continuity throughout the transition.

As with any significant change, the move created early uncertainty among internal team members. Many were required to adapt to new responsibilities or redefine their roles entirely. This disruption led to a temporary dip in morale, a lack of clarity around expectations, and growing concern about how the transition would impact ways of working and team cohesion. The challenge was not just operational—it was also deeply human.

 

The Approach:

I was engaged to lead the project end-to-end, bringing structure, transparency, and alignment across workstreams.

Key activities included:

• Set clear project milestones and ensured delivery within agreed timelines and budget.
• Identified and coordinated key workstreams; partnered with workstream leads to:
  • Develop workstream charters.
  • Map affected SOPs and create update plans.
  • Identify interdependencies and implement mitigation strategies.
  • Establish RACI frameworks for clarity of roles.
• Created and executed a comprehensive communication plan to support the rollout of changes.
• Conducted stakeholder mapping and an initial risk assessment; developed mitigation plans and ensured adequate resourcing.
• Consolidated vendor information across countries and collaborated with local managers and regulatory teams to align outsourcing needs.
• Held regular meetings with workstream leads to provide clarity, resolve challenges, and escalate issues effectively.
• Presented progress and risk mitigation updates to senior leadership throughout the project lifecycle.
• Prioritised team cohesion by creating space for open dialogue, addressing uncertainty, and encouraging collaboration—ultimately transforming a disrupted team into a more connected and supportive one.

 

The Outcome:

 

As project lead, I guided the transition from planning through execution—ensuring delivery on time and within budget while maintaining strong stakeholder alignment. As a team, we proactively identified and mitigated risks, keeping the focus on regulatory compliance and operational continuity. Under my leadership, all workstreams transitioned smoothly to the strategic partner, with updated or planned SOPs in place to support long-term consistency and quality.

Beyond operational success, I worked closely with internal teams to manage the human side of change. Through clear communication, regular check-ins, and collaborative problem-solving, I helped rebuild morale, clarify roles, and strengthen cross-functional relationships. The transition not only achieved its immediate goals but also laid the groundwork for a more cohesive, resilient, and adaptable team.

While the formal handover marked a key milestone, the journey continues. Transitions of this scale require ongoing iteration, feedback, and refinement. With strong foundations established, the organisation is now better positioned to thrive within a more strategic, partnership-led model.