Regulatory Senior Project Manager

BioMarin Pharmaceutical Inc. (Swiss Office) seeks a Senior Regulatory Project Manager to drive efficiency within the Global Regulatory Affairs & Patient Safety department, supporting global strategies and cross-functional teams.

This position operates within the Global Regulatory Affairs & Patient Safety (GRAPS) department. The primary objective is to enhance the efficiency and effectiveness of regulatory or cross-functional sub-teams by partnering closely with the Global Regulatory Lead.

Responsibilities

• Support the development and execution of global regulatory strategies and daily operations.
• Create and maintain project schedules spanning from pre-clinical stages through the entire product lifecycle.
• Monitor progress and ensure timely completion of all action items.
• Coordinate with Project Managers across other functions to align regulatory timelines with broader project goals.
• Design and update dashboards that visualize key regulatory activities for project and cross-project oversight.
• Record and monitor the status of global regulatory submissions and approvals using the designated tracking system.
• Organize, prepare agendas for, and facilitate Global Regulatory Team (GRT) meetings.
• Arrange and lead Regulatory Advisory Board (RAB) sessions.
• Act as the regulatory representative on the Production Integration Management Team (PRIME).
• Identify and execute process improvements within the GRAPS framework.

Requirements

• A degree in health or life sciences, such as chemistry or molecular biology.
• At least six years of professional experience if holding a Master’s degree or MBA, or eight years with a bachelor’s degree.

Nice to have

• A Master’s degree or MBA is preferred.
• Prior experience managing projects within a biotechnology or pharmaceutical organization is advantageous.

About the company

BioMarin Pharmaceutical Inc. is a prominent biotechnology firm specializing in treatments for genetically defined rare diseases. The organization is driven by a mission to create therapies that significantly improve patient lives. Its success is built on a dedication to excellence, deep insight into patient needs, scientific mastery, and advanced manufacturing capabilities.

• Focus on developing medicines for rare, genetically defined conditions.
• Commitment to making a profound impact on patients' lives.
• Values include excellence, patient-centric understanding, scientific expertise, and world-class manufacturing.