Director Worldwide Regulatory Operations resume example

I led a team that designed and installed a new organization, Global Dossier Management. This was in response to the redundancies of roles and inefficiencies as a result of the merger of the Regulatory Coordination and Regulatory Operations departments. This was a multi-year, multi-phased project in which roles were eliminated, merged and redefined to focus on active management of activity rather than passive tracking. By combining roles and focusing on core submission management activity, a savings of 11 (22%) FTEs was realized.

Aligned the team to support the increased activity as a result of the Schering Plough merger, a~50% increase product workload associated with merger with only a 16% staff increase.Expanded the role to the European office to build regional expertise to support the company’s most complex regulatory environment.

Ongoing reevaluation of the organization, making changes to support the changing environment. For example the need to support emerging market objectives.

I managed the Submission Manufacturing project to reduce global submission release cycle time. This was a 3 phase project that focused on both process and enabling technology. The single date approach was eliminated and replaced with data-driven requirements based on size and complexity. This project also included the implementation of an enabling technology to facilitate detailed, proactive submission management and replace multiple tracking methods.

Reduced Global Release Cycle time from 150 days to 90 days

10-14 days of waste (touch time) eliminated per filing for small submissions and 5-8 days of waste eliminated per filing for medium/large submissions

Partnered with Octagon Research to develop and deliver a new technology that supports dynamic, multi-regional planning and delivery.

Project won Merck-wide Sigma innovation award

I assumed the leadership of two work streams for the Global Product Registration Management Team when the sponsors identified that the time lines were in jeopardy. The documentation workstream included the creation of multiple SOPs, User Guides and Training Materials. I quickly analyzed the problems facing the team and facilitated a significant change in scope to ensure usable training and materials would be produced on time. The UAT workstream was an end-of-year MRL objective that required managing both internal and contract resources. I successfully led the team to completion of the UAT to meet the objective,

Developed e-learning for company-wide users that allowed us to decrease the amount of hands-on training.

When it was identified that regional trainers could not be installed on time, worked to develop GRO resources to fill the gap. This team of 8 trained more than 600 worldwide users prior to go live.

Implemented a new UAT schedule and daily objective calls to accelerate test script execution.