Global Regulatory Submissions Lead

Ipsen Biopharmaceuticals Inc.; Greater London; On-site; GBP 70,000 - 110,000; Full time

Job summary

Ipsen Biopharm Ltd is seeking a Senior Regulatory Submission Project Manager to lead global, cross-functional teams in planning, coordinating, and delivering high-quality regulatory submissions. The role requires strong project management, regulatory affairs expertise, and experience with international CTD filings to support complex product development strategies.

You will work with Regulatory Affairs, Clinical, Quality, Manufacturing, and other functions to ensure timely, compliant submissions

Qualifications

• Experience in the pharmaceutical industry with a focus on regulatory submission management (project management).
• Strong experience leading submission processes and CTD filings on an international level.
• Good understanding of drug development, strategy, and managing complex products/projects at international level.
• Knowledge of eCTD publishing, Regulatory Information Management (RIMS), and regulatory submission technologies.

Responsibilities

• Lead global cross-functional submission teams to plan, coordinate, and deliver regulatory submissions.
• Develop, maintain and manage integrated submission timelines as part of a project plan, identifying interdependencies and mitigating risks.
• Coordinate submission deliverables across functional areas, ensuring document readiness and regulatory compliance.
• Provide regular updates to stakeholders on submission status, milestones, risks and key decisions.
• Champion best practices, lessons learned, and continuous improvement initiatives in submission management.

Skills

Regulatory submissions

Project management

CTD/eCTD

Cross-functional collaboration

Regulatory affairs

Multicultural awareness

Organizational skills

Tools

Project management tools

Job description

Ipsen Biopharm Ltd is seeking a Senior Regulatory Submission Project Manager to lead global, cross-functional teams in planning, coordinating, and delivering high-quality regulatory submissions. The role requires strong project management, regulatory affairs expertise, and experience with international CTD filings to support complex product development strategies.

You will work with Regulatory Affairs, Clinical, Quality, Manufacturing, and other functions to ensure timely, compliant submissions