Regulatory Strategy Lead (On-site, Valby)

Job summary

We are seeking two experienced Regulatory Strategy Leads to support late-stage development programs aimed at addressing neurological disorders. This role involves aligning global regulatory strategies with local registration requirements and may include acting as the EU regulatory lead or facilitating communication between global and regional regulatory teams.

Qualifications

• University degree in life sciences or a medical discipline; PhD is a plus.
• Proven experience with global regulatory strategies and health authority interactions.
• Understanding of drug development, particularly in CNS, biologics, or rare diseases is advantageous.
• Strong communication skills in English, both written and spoken.

Responsibilities

• Collaborate with the Global Regulatory Strategy Lead to develop innovative regulatory approaches.
• Support planning for Health Authority interactions and contribute to clinical development strategies.
• Assess regulatory risks and identify mitigation strategies.
• Review evidence packages and submission approaches with a focus on regulatory expectations and patient benefit.
• Work within a cross-functional team to advance development and registration activities.

Skills

• Ability to navigate complex environments and manage competing priorities.
• Strong collaboration and influencing skills across diverse teams and organizational levels.
• Innovative mindset with solid matrix leadership capabilities.

Education

• Relevant university credentials in life sciences or medical discipline; PhD is an advantage.

Tools

• Familiarity with regulatory submission tools and processes is beneficial.