Do you like to make things happen? Do you have solid regulatory affairs (RA) experience, and are you able to take the regulatory lead on a very ambitious growth strategy? Then this job could be your perfect match.

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. You will enter LEO Pharma at the most exciting period of time. Right now, we are transforming the business to meet the requirements of tomorrow, maximizing opportunities by defining differentiated global regulatory strategies with optimized roll out plans.

In Global Regulatory Affairs you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job as Senior Global Regulatory Lead you will create and drive the global regulatory strategy for a product(s) / project(s) and ensure there is a sound regulatory foundation for the successful optimization of the product(s) /project(s) in accordance with business priorities working closely with RA subfunctions (including regional RA leads) and global cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on global project strategy.

• Strategic lead of the Global Regulatory Team (GRT) and overall accountable for creating and driving global regulatory strategies for assigned project(s)/product(s) within the Innovative Portfolio.
• Define regulatory strategic direction, review and provide critical regulatory input into documents that will be included in regulatory applications and interactions, as applicable
• Accountable for securing coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs, MAV/sNDA)
• Represents GRA to Global Project Teams (GPT) within the Innovative Portfolio
• Act as people manager for a team of dedicated EU, US leads and Regulatory Professionals, as allocated
• Allocate budgets within predefined portfolio.

The ideal candidate will maintain expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations and competitive intelligence/landscape. The candidate will provide clear and valid regulatory guidance, interpretation by applying ‘out of the box thinking’ mind set, direction to GRT , GPT and other global functional subteams. She/he will act pro-actively and sustain a good stakeholder collaboration within GRA and across the LEO Pharma organization via continuous stakeholder management.  Your qualifications