Global Regulatory Strategy Lead - Hybrid CNS

Cari; København; Hybrid; DKK 786,000 - 1,081,000; Full time

Job summary

Lundbeck is seeking a Global Regulatory Strategy Lead to shape the strategy for a Phase 2 CNS development programme and coordinate its execution. The role requires representing Regulatory Affairs in a global project team and leading the RAFT to advance development and plan regulatory interactions with health authorities.

You will contribute regulatory insight to key decisions, explore innovative approaches, and help shape development plans across the lifecycle.

Qualifications

• University degree in life science or medical discipline (PhD welcome but not essential).
• Experience developing global regulatory strategies, including interactions with health authorities.
• Involvement in global new drug applications and regulatory submissions.
• Broad understanding of science and drug development with curiosity beyond Regulatory Affairs.
• Innovative mindset with matrix leadership and ability to influence at all levels.
• Advanced communication skills in English (written and spoken).

Responsibilities

• Shape and drive the global regulatory strategy for a Phase 2 programme.
• Represent Regulatory Affairs in a global cross-functional project team.
• Lead the Regulatory Focus Team (RAFT) with regional leads and other experts.
• Opportunity to lead an early phase programme.
• Support decision making by providing regulatory insights and risk assessments.

Skills

Matrix leadership

Communication

English proficiency

Education

Life science degree

PhD welcomed

Job description

Lundbeck is seeking a Global Regulatory Strategy Lead to shape the strategy for a Phase 2 CNS development programme and coordinate its execution. The role requires representing Regulatory Affairs in a global project team and leading the RAFT to advance development and plan regulatory interactions with health authorities.

You will contribute regulatory insight to key decisions, explore innovative approaches, and help shape development plans across the lifecycle.