Global Regulatory Submissions Lead

Ipsen; Paris; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Ipsen Biopharm Ltd in Paris, Île-de-France, seeks a Regulatory Submission Project Manager to lead global regulatory submissions from planning to delivery across regions. You will coordinate cross-functional teams across Regulatory Affairs, Clinical, Quality, and Manufacturing to ensure on-time, compliant submissions.

The ideal candidate has proven experience in international CTD/eCTD submissions, strong project management skills, and excellent stakeholder communication.

Qualifications

• Experience in pharma regulatory submissions and project management.
• Experience leading submission processes internationally.
• Understanding of drug development and international strategy.
• Strong organizational and multitasking abilities.
• Experience coordinating cross-functional teams.

Responsibilities

• Plan, coordinate, and deliver regulatory submissions on time.
• Lead global cross-functional submission teams.
• Develop and manage submission timelines and milestones.
• Collaborate with Regulatory Affairs, Clinical, QA, Manufacturing.
• Ensure compliance with CTD/eCTD requirements.

Skills

Regulatory submissions

Project management

Cross-functional leadership

CTD/eCTD knowledge

English fluency

Education

Degree in scientific discipline

Tools

eCTD publishing

RIMS

Regulatory submission tools

Job description

Ipsen Biopharm Ltd in Paris, Île-de-France, seeks a Regulatory Submission Project Manager to lead global regulatory submissions from planning to delivery across regions. You will coordinate cross-functional teams across Regulatory Affairs, Clinical, Quality, and Manufacturing to ensure on-time, compliant submissions.

The ideal candidate has proven experience in international CTD/eCTD submissions, strong project management skills, and excellent stakeholder communication.