Associate Director, Global Regulatory Strategy

IQVIA; Oeiras; Presencial; EUR 150 000 - 190 000; Tempo integral

Resumo da oferta

IQVIA is seeking an experienced Associate Director, Regulatory Affairs to lead complex global regulatory projects for pharmaceutical and biotechnology clients, focusing on strategy, submissions, and health authority interactions.

This client-facing individual contributor role demands strong project leadership, risk management, and cross-functional collaboration across global development programs to deliver compliant regulatory solutions.

Qualificações

• Bachelor's or Master's degree in a life sciences discipline.
• Extensive Regulatory Affairs experience in pharma/biotech/CRO/consulting.
• Experience leading regulatory projects and client engagements.

Responsabilidades

• Serve as Project Lead or Regulatory Lead overseeing multiple projects.
• Develop regulatory strategies to support global development and registration.
• Lead preparation of submission documents (IMPDs, IND meetings, iPSPs/PIPs, fast track designations).
• Coordinate regulatory documentation and compliant submissions (BLA/NDAs/MAA, IND/CTAs).
• Provide strategic regulatory guidance to project teams and clients.
• Act as the regulatory authority contact for assigned projects (FDA/EMA/MHRA).
• Assess regulatory risks and develop mitigation strategies.
• Manage budgets, timelines, and resource planning.

Conhecimentos

Regulatory leadership

Project management

Stakeholder management

Regulatory strategy

Regulatory submissions

English communication

Formação académica

Bachelor's or Master's in life sciences

Descrição da oferta de emprego

IQVIA is seeking an experienced Associate Director, Regulatory Affairs to lead complex global regulatory projects for pharmaceutical and biotechnology clients, focusing on strategy, submissions, and health authority interactions.

This client-facing individual contributor role demands strong project leadership, risk management, and cross-functional collaboration across global development programs to deliver compliant regulatory solutions.