Overview In this role you will lead global regulatory submission projects to secure new marketing authorisations and indications. You will partner with Regulatory Affairs, Clinical, Quality, Manufacturing and other functions to plan, coordinate, and deliver compliant submissions on time. You will drive risk mitigation, scenario planning, and continuous improvement to enhance submission quality and efficiency. This position offers an opportunity to shape international submissions within a collaborative, cross-functional team at Ipsen.
Responsibilities - Lead global cross-functional submission teams to plan, coordinate, and deliver regulatory submissions across regions.
- Develop and manage integrated submission timelines and identify interdependencies and risks.
- Coordinate submission deliverables and ensure document readiness and regulatory compliance.
- Lead submission planning activities, including kick-offs and materials to facilitate decisions.
- Create submission forecasts and communicate status, milestones, risks and decisions to stakeholders.
- Drive risk mitigation and issue resolution to maintain schedules and quality.
- Champion best practices and continuous improvement in submission management processes.
Key requirements - Experience in pharmaceutical Regulatory Affairs with focus on regulatory submission management (project management).
- Strong experience leading submission processes and CTD filings internationally.
- Solid understanding of drug development, strategy and international product management.
- Excellent organizational and stakeholder management skills; experience leading complex submissions.
- Experience with project management tools.
- Cross-functional collaboration
- Stakeholder management
- Strategic thinking and scenario planning
- CTD/eCTD knowledge
- eCTD publishing
- RIMS familiarity
