Global Regulatory Submissions Lead

Ipsen Biopharmaceuticals Inc.; Greater London; On-site; GBP 90,000 - 120,000; Full time

Job summary

Ipsen Biopharm Ltd in the United Kingdom is seeking a Regulatory Submission Project Manager to plan, coordinate, and delivery high-quality regulatory submissions on a global scale. You will work closely with Regulatory Affairs, Clinical, Quality, and Manufacturing teams to align strategy and timelines.

The role requires strong project management skills, international submission experience, and a deep understanding of CTD/eCTD frameworks.

Qualifications

• Experience in regulatory affairs with a focus on submission management.
• Lead submission processes and CTD filings internationally.
• Strong understanding of drug development and international regulatory strategies.

Responsibilities

• Plan, coordinate, and deliver regulatory submissions across regions.
• Develop and execute submission project plans for marketing authorisations and indications.
• Oversee preparation, review, and delivery of global submissions.
• Lead cross-functional teams with Global Regulatory Leads to ensure on-time delivery.
• Maintain integrated submission timelines and manage risks across regions.
• Communicate status, milestones, and key decisions to stakeholders.

Skills

Regulatory submissions

Project management

Cross-functional collaboration

Risk mitigation

CTD/eCTD understanding

Regulatory strategy

Tools

eCTD publishing

RIMS

Regulatory submission tools

Job description

Ipsen Biopharm Ltd in the United Kingdom is seeking a Regulatory Submission Project Manager to plan, coordinate, and delivery high-quality regulatory submissions on a global scale. You will work closely with Regulatory Affairs, Clinical, Quality, and Manufacturing teams to align strategy and timelines.

The role requires strong project management skills, international submission experience, and a deep understanding of CTD/eCTD frameworks.