Global Regulatory Strategy Lead - CNS & Global Submissions

Lundbeck A/S, H; København; Hybrid; DKK 1,109,000 - 1,525,000; Full time

Job summary

Lundbeck is seeking a Global Regulatory Strategy Lead, Senior Director, in Copenhagen, Denmark, hybrid option. You will shape the global regulatory direction for development programs, influence strategic decisions, and partner with cross-functional teams to drive successful regulatory outcomes.

The role requires 10+ years in R&D with 7+ years in Regulatory Affairs, strong English communication, and a PhD is advantageous. Annual base salary range is provided, with a transparent pay approach.

Qualifications

• 10+ years of R&D experience in a pharmaceutical or biotech industry.
• 7+ years of Regulatory Affairs experience.
• Experience with regulatory project management and new drug submissions/approvals.
• Scientific understanding of CNS, biologics or rare diseases is advantageous.
• Strong communication and influence across cross-functional teams.

Responsibilities

• Shape and lead global regulatory strategies supporting ambitious development objectives.
• Influence critical development decisions through regulatory perspectives.
• Challenge conventional thinking and identify innovative regulatory approaches.
• Drive strategic Health Authority engagement and translate feedback into development actions.
• Lead through influence across functions and regions to achieve aligned decisions.

Skills

Regulatory strategy

Project management

Regulatory submissions

Strategic leadership

CNS knowledge

English communication

Education

PhD in life sciences

Job description

Lundbeck is seeking a Global Regulatory Strategy Lead, Senior Director, in Copenhagen, Denmark, hybrid option. You will shape the global regulatory direction for development programs, influence strategic decisions, and partner with cross-functional teams to drive successful regulatory outcomes.

The role requires 10+ years in R&D with 7+ years in Regulatory Affairs, strong English communication, and a PhD is advantageous. Annual base salary range is provided, with a transparent pay approach.