Provide leadership of global, US, and EU regulatory leads to create and drive the regulatory strategy for the innovative portfolio and ensure that there is a sound regulatory foundation to help drive the clinical development and LCM opportunities of the portfolio.

The leader and their team have primary responsibility for the global regulatory strategy, regulatory interactions, and submissions, with direct accountability for US and EU centralized procedure and input with EU affiliates for national procedures (where applicable). Plays a leadership role providing management and guidance across the strategy function

Job Tasks

• Formulate and oversee implementation of regulatory strategies and activities needed to secure and maintain approval of LEO Pharma’s innovative portfolio globally.
• Manage coordination, preparation and timely submission of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs).
• Review and critique documents that will be included in regulatory applications and interactions, as applicable.
• Maintain expert knowledge of, and familiarity with, FDA/EMA/key international market regulations and ICH guidelines.
• Provide clear and valid regulatory guidance and direction to other departments and project teams.
• Represent regulatory strategy at Development Science Committee and other LEO governance forums. 
• Develop and maintain relationships with external vendors and health authorities in support of executing innovative portfolio strategy for global and local considerations.
• Supervise team members and consultants to the Regulatory Affairs department.
• Foster strong relationships and advocacy with FDA, EMA and in partnership with local regulatory and other international regulatory authorities. 
• Build strong coordination and collaboration across cross-functional stakeholders.
• Provide guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities.
• Responsible for demonstrating LEO Pharma leadership behaviors.

• 12+ years pharmaceutical industry and 10+ relevant global strategic regulatory experience and 7+ years managerial experience (resource, capacity, performance and change management)
• In-depth therapeutic strategy RA experience on a global level for both development and maintenance phases for pharmaceuticals.
• Solid knowledge of the regulatory framework.
• Excellent strategic thinking.
• Solid stakeholder management skills
• Commercial understanding.
• Sound understanding of the drug development process with specific focus on drug development from early research through life cycle management considerations.
• Excellent ability to identify multiple regulatory opportunities, whilst being able to clearly communicate regulatory constraints, risks, and identify various risk mitigation strategies to support business objectives.