A fantastic new opportunity has been created for a leading, global pharmaceutical company, which can be based in (Switzerland, Germany or the USA) primarily a remote/hybrid position.

My client is a market leader, at the frontier of drug research and development, with promising first-in-class and potential medical breakthrough pipeline projects.

The Global Submission Snr/Director will be building out this new role/division while working closely with the Global Regulatory Affairs department and Regulatory Support Services. Leading a team of circa 20-30FTE you will also be part of the senior leadership team, supporting the different responsibilities in submission processes and development Globally.

• Responsible for identifying, recruiting, and retaining top talent, conducting interviews, and fostering a positive and productive work environment
• Your leadership will be pivotal in ensuring the Global Regulatory Affairs (GRA) team’s ability to efficiently deliver timely, high-quality worldwide submissions
• Continuously drive operational efficiency by exploring innovative ways of working and optimising processes
• Tasked with prioritizing, planning, preparing, and coordinating submissions for my client portfolio across key global markets
• Manage vendor relationships, overseeing performance management, resource allocation, and turnover mitigation
• Participate in governance committees, adapting the operating model as needed to ensure continued success and evolution in service deliver
• Key member of the Global Regulatory Affairs Leadership team, contributing to the overall department strategy
• Lead strategic oversight and management of the Global Labeling processes
• Provide quality and compliance oversight for the labeling process in line with regulatory and GxP requirements

Job requirements:

• Extensive Global Regulatory Affairs Expertise in the pharmaceutical industry, with expertise in CMC, labeling, regulatory operations, dossier preparation, and compliance for both core and international markets
• Proven Leadership in Global Teams, leading high-performing, diverse regulatory teams across multiple time zones, with a track record of building and managing global teams
• Strategic and Solution-Oriented: Highly flexible and pragmatic, with an independent and proactive working style. Skilled at linking long-term vision to daily operations and successfully navigating matrix environments to influence and drive results. Fluent in English

Early applications are highly encouraged.

If you have the skills and experience for this opportunity and the ambition to take on this position, please contact Vicki for further details or email your CV today.

• By email: vicki.taggart@hayburysearch.com
• By phone: +44 (0)1273 059 648 / +44 (0)7881 555 382

Vicki is a Senior Business Unit Head at Haybury covering Europe, UK, North America and Asia.