Global Regulatory Submissions Lead - Project Mgmt

Ipsen; Paris; Hybride; EUR 80 000 - 120 000; Plein temps

Résumé du poste

Ipsen Biopharm Ltd in France seeks a Regulatory Submission Project Manager to lead cross‑functional teams and manage global regulatory submissions.

You will develop submission plans for new marketing authorisations and indications, coordinate timelines, drive risk mitigation, and ensure CTD/eCTD compliance to support on‑time delivery across regions.

Strong experience in international submissions, project management tools, and a proactive, collaborative style are essential.

Qualifications

• Experience in Regulatory Affairs focused on regulatory submission management (project management).
• Strong experience in leading submission processes and CTD filings internationally.
• Understanding of drug development, strategy, and managing complex products/projects at international level.
• Multicultural awareness and sensitivity; excellent organizational and management skills.
• Prior leading role on complex submission or excellence projects with multiple stakeholders.

Responsabilités

• Plan, coordinate, and deliver high-quality regulatory submissions with cross-functional teams.
• Develop and execute submission project plans for new marketing authorisations and indications.
• Manage submission timelines, scenario planning, and risk mitigation across regions.
• Oversee preparation, compilation, review, and delivery of global regulatory submissions.
• Lead submission planning activities and coordinate with Global Regulatory Leads.
• Create submission forecasts and provide regular updates to stakeholders.

Connaissances

Regulatory submissions management

Project management

Cross-functional leadership

CTD/eCTD framework

Regulatory affairs

Multicultural awareness

Formation

Degree in scientific discipline

Outils

Project management tools

Description du poste

Ipsen Biopharm Ltd in France seeks a Regulatory Submission Project Manager to lead cross‑functional teams and manage global regulatory submissions.

You will develop submission plans for new marketing authorisations and indications, coordinate timelines, drive risk mitigation, and ensure CTD/eCTD compliance to support on‑time delivery across regions.

Strong experience in international submissions, project management tools, and a proactive, collaborative style are essential.