Global Regulatory Strategy Lead - CNS & Early Phase

Lundbeck A/S, H; København; Híbrido; DKK 786.000 - 1.081.000; Jornada completa

Descripción de la vacante

Lundbeck A/S in Valby, Denmark, is seeking a Global Regulatory Strategy Lead to shape and drive regulatory strategy for CNS development programmes, coordinating execution for a Phase 2 programme.

You will represent Regulatory Affairs in global cross-functional teams, lead the RAFT, and have the opportunity to lead an early phase programme. Hybrid working options may be considered based on residence.

Formación

• University degree in life science or medical discipline; PhD welcomed but not essential.
• Experience developing global regulatory strategies with health authorities.
• Broad understanding of science and drug development.
• Innovative mindset with matrix leadership and influence across the organisation.
• Advanced written and spoken English proficiency.

Responsabilidades

• Shape and drive the global regulatory strategy and coordinate its execution for a Phase 2 development programme.
• Represent Regulatory Affairs in a global, cross-functional project team and build partnerships across disciplines.
• Lead the Regulatory Focus Team (RAFT) to advance development and plan regulatory activities with health authorities.
• Have the opportunity to lead an early phase programme.
• Provide regulatory insight and scientific perspectives to key decisions and risk mitigation.
• Contribute to clinical development plans and cross-l lifecycle discussions.

Conocimientos

Regulatory strategy

Matrix leadership

Stakeholder influence

English communication

Educación

University degree in life science or medical discipline

PhD welcomed but not essential

Descripción del empleo

Lundbeck A/S in Valby, Denmark, is seeking a Global Regulatory Strategy Lead to shape and drive regulatory strategy for CNS development programmes, coordinating execution for a Phase 2 programme.

You will represent Regulatory Affairs in global cross-functional teams, lead the RAFT, and have the opportunity to lead an early phase programme. Hybrid working options may be considered based on residence.