EU Regulatory Lead

Description

The EU Regulatory Lead (EU RL) is responsible for the regulatory strategy and execution for their assigned projects in their EU region and respective countries.

The EURL represent and provide input for the respective EU region at the GRST. The person may provide direct input to the GPT in case of major region, particularly where the GRL is not in that region.  

The person lead the respective regional regulatory sub-team and drive the regulatory submission in the EU region.

The person ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance.

Partnering with Regulatory Project Management and Submission Management is a key stakeholder management. The person participate in cross-functional and GRA initiatives.

Qualifications

• Considerable Regulatory Affairs experience
• Advanced scientific degree or equivalent
• Minimum 3 years of experience in drug development, preferably in Regulatory Affairs
• Skilled in matrix leadership
• Influencing and interpersonal communication skills
• Excellent spoken and written English