Global Regulatory Lead - Mindlance : Job Details

Estimate Start Date July 7 th t LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities! Your Role s a Global Regulatory Lead you will be overall accountable for global regulatory strategies and deliverables to development and life cycle management activities.

• Provide global regulatory leadership throughout the lifecycle of development and/or marketed product program(s). Ensure that input from global Health Authorities as well as regional and functional collaborators is collated to build a coherent, global, regulatory strategy which fulfills TPP and portfolio objectives.
• Develop comprehensive global regulatory strategies that takes into account worldwide regulatory requirement to drive product development, global registration, achievement of desired labeling, and effective regulatory agency interactions
• Lead Global Regulatory Teams (GRTs), with focus on developing high performance teams
• Provide regulatory expertise and guidance to project teams
• Represent Regulatory Affairs in cross-functional project teams
• Maintain expert knowledge on regulatory environment, guidelines, competitor landscape in the US, EU, and key international markets
• Plan and execute global regulatory submissions (e.g., MAA/NDA, CTA/IND, label extensions, PIP/PSP)
• Review/approve key regulatory documents (e.g., briefing documents,, documents for regulatory submissions , core labeling)

• Master's or Bachelor's degree in Natural Sciences (Master's preferred) or equivalent
• 10+ years of experience in the pharmaceutical industry with increasing global strategic regulatory responsibilities
• Proven track record of leading key regulatory milestones (e.g., EOP2, MAA/NDAs, line extensions) with major business impact
• Strong knowledge of global regulatory frameworks across both development and life cycle management phases
• Expert understanding of ICH guidelines and major health authority requirements (US, EU, Japan, China)
• Broad business acumen and understanding of project impact
• Strategic thinker with a curious, proactive, and solution-oriented mindset
• Strong team player and effective communicator
• Skilled in stakeholder management, balancing multiple priorities
• High personal drive, positive attitude, and strong commitment