Global Regulatory Lead

Titlul postului:

Global Regulatory Lead

Companie

Leo Pharma

Descrierea postului

Location: Ballerup 2750, Denmark, Denmark
Contract type: Permanent
Job ID: 3138Do you want to be part of LEO Pharma’s transformation journey, this is your chance to be part highly skilled team where responsibility, impact and fun will be an essential part of your daily work. At LEO Pharma, we are dedicated to helping people achieve healthy skin through groundbreaking treatments. We invite you to join our Regulatory Project Strategy team where you will play a crucial role.Shape the LEO Pharma of tomorrowAt 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
As 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)

Your Qualifications

• 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

Your New TeamWelcome to the Regulatory Project Strategy team at LEO Pharma! Here, you will join an experienced and highly motivated team of Global Regulatory Leads and Intelligence Specialists, who are committed to a learning culture and supporting team members in achieving both business goals and personal development goals.Contact and ApplicationReady to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application!At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.For certain positions, LEO Pharma might complete a background check conducted by a third party.Report a concern:

Salariu așteptat

Locație

Ballerup, Hovedstaden

Data jobului

Tue, 29 Apr 2025 22:59:01 GMT

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