Global Regulatory Submissions Lead

Ipsen; Greater London; Presencial; GBP 75 000 - 95 000; Tempo integral

Resumo da oferta

Ipsen in London is seeking a Regulatory Submission Manager to lead global submission activities, coordinating cross-functional teams across regions and stakeholders. You will drive project planning, timelines, and risk mitigation to ensure timely regulatory authorisations and registrations.

The role requires deep knowledge of CTD/eCTD, strong project management skills, and the ability to influence global teams in a matrix environment. Fluency in English and a scientific degree are essential.

Qualificações

• Experience in regulatory affairs 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.

Responsabilidades

• Lead global cross-functional submission teams to plan, coordinate, and deliver regulatory submissions.
• Collaborate with Global Regulatory Affairs to execute submission strategies and align with product development goals.
• Develop, maintain, and manage integrated submission timelines as part of a project plan; identify interdependencies and mitigate risks.
• Lead submission planning activities, including kick-off meetings and materials for decision-making with Global Regulatory Leads.
• Coordinate identification of submission risks and drive issue resolution to maintain schedule and quality.
• Coordinate submission deliverables across functions, ensuring readiness and regulatory compliance.
• Create and maintain submission forecasts to support portfolio planning and decision-making.
• Develop communication plans and provide regular updates on status, milestones, risks, and decisions.
• Champion best practices and continuous improvement to enhance submission processes and efficiency.

Conhecimentos

Regulatory submissions

Project management

Cross-functional leadership

CTD/eCTD

Global regulatory

Organizational skills

Multicultural awareness

Project management tools

Formação académica

Degree in scientific discipline

Ferramentas

RIMS

eCTD publishing

Regulatory submission technologies

Descrição da oferta de emprego

Ipsen in London is seeking a Regulatory Submission Manager to lead global submission activities, coordinating cross-functional teams across regions and stakeholders. You will drive project planning, timelines, and risk mitigation to ensure timely regulatory authorisations and registrations.

The role requires deep knowledge of CTD/eCTD, strong project management skills, and the ability to influence global teams in a matrix environment. Fluency in English and a scientific degree are essential.