Director Global Regulatory Affairs

About the role

The Director of Regulatory Affairs will provide strategic leadership for the development and execution of global regulatory strategies across a diverse portfolio of innovative products. This role involves guiding cross-functional teams through complex regulatory challenges, ensuring regulatory excellence throughout the product lifecycle, and driving successful product registrations in major global markets with a focus on Europe. The position serves as a key strategic partner to senior management to enable efficient product development and sustainable compliance.

Responsibilities

• Contributes to the development, maintenance, and implementation of global regulatory strategies for assigned products, projects, and submissions.
• Supports strategic and operational regulatory planning across development, registration, and post-authorisation phases.
• Supports preparation, critical review, coordination, and submission of regulatory documents including clinical trial and marketing authorisation applications.
• Provides regulatory input to cross-functional teams to support compliant development plans, clinical trial designs, and labelling considerations.
• Supports health authority interactions by coordinating input, preparing briefing materials, and participating in meetings.
• Monitors evolving regulatory requirements, legislation, and external expectations to assess potential impact on projects.
• Coordinates with internal functions, affiliates, and external partners to support timely and compliant delivery of regulatory activities.

Required skills

• Global Regulatory Affairs
• Drug development
• Regulatory strategy
• Lifecycle management
• Regulatory submissions
• Health authority interactions

Qualifications

• University degree in Medicine, Pharmacy, Life Sciences, Chemistry, or another relevant scientific discipline
• Advanced degree