Regulatory Submission Project Manager

Overview

In this role you will lead global regulatory submission efforts to support new marketing authorisations and indications. You will collaborate across Regulatory Affairs, Clinical, Quality and Manufacturing to plans, coordinate, and deliver compliant submissions on time. You will apply project management practices and regulatory know-how to optimize submission quality and timelines, driving cross-functional alignment and continuous improvement. This is an opportunity to shape regulatory strategy and enable product development across regions in a fast-paced, collaborative environment.

Responsibilities

• Lead global cross-functional submission teams to plan, coordinate, and deliver regulatory submissions
• Develop and manage integrated submission timelines with interdependencies and risk mitigation
• Coordinate submission deliverables across functional areas ensuring document readiness and regulatory compliance
• Lead submission planning activities including kick-off meetings and scenario planning
• Create and maintain submission forecasts aligned with global strategy plans
• Develop communication plans and update stakeholders on status, milestones, risks, and decisions
• Champion best practices and continuous improvement in submission management processes

Key requirements

• Experience in regulatory affairs with focus on regulatory submission management (project management) in the pharmaceutical industry
• Strong experience leading submission processes and CTD filings internationally
• Understanding of drug development, strategy, and management of complex international projects
• Strong multi-cultural awareness and excellent organizational skills
• Prior leading role on complex submission or excellence projects with multiple stakeholders
• Experience with project management tools
• Degree in scientific discipline
• Fluent in English

• cross-functional collaboration
• stakeholder management
• risk management
• CTD/eCTD framework
• regulatory submission technologies
• eCTD publishing

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