Senior Regulatory Consultant – GRL

Overview

In this role you will shape global regulatory strategy for oncology and biotech products, spanning EU and worldwide markets. You will collaborate with cross-functional teams to drive lifecycle management, post-approval activities, and regulatory submissions. You’ll lead regulatory guidance, risk assessment, and strategic decision-making to ensure compliant product trajectories. This position offers impact across markets, contributing to milestones from development through commercialization. You will work in a fast-paced, matrixed environment with a strong emphasis on cross-border regulatory leadership and execution.

Responsibilities

• Act as a member of EU and Global Regulatory Teams for assigned programs
• Develop and execute global regulatory strategies for post-approval products
• Provide strategic regulatory guidance to cross-functional teams
• Review and approve regulatory documents and submissions for global markets
• Support regional regulatory teams ensuring alignment with global objectives
• Participate in Health Authority interaction planning and address regulatory queries
• Represent Regulatory Affairs within multidisciplinary product teams
• Contribute regulatory insights during quarterly safety reviews and benefit-risk discussions
• Identify regulatory risks and propose actionable solutions
• Lead EU lifecycle management activities including variation submissions
• Oversee labeling updates across European markets
• Prepare and coordinate PSURs and renewal submissions
• Maintain Marketing Authorisations and ensure ongoing regulatory compliance
• Manage regulatory aspects of clinical trials including substantial amendments
• Provide guidance on emerging EU regulatory requirements and their impact on strategy

Key requirements

• Extensive experience in Regulatory Affairs within biotechnology or pharmaceutical industry
• Proven expertise as Global Regulatory Lead or in global regulatory strategy for innovative products
• Strong knowledge of EU and global regulatory frameworks
• Significant experience in post-approval lifecycle management and marketed products
• Proficiency in European regulatory procedures including variations, renewals, labeling updates, PSURs
• Ability to assess complex regulatory challenges and develop practical solutions
• Experience reviewing and approving regulatory documentation for international markets
• Excellent communication, negotiation, and stakeholder management skills

• excellent communication
• negotiation
• stakeholder management
• EU regulatory procedures
• PSURs
• variations

…