Principal Regional Regulatory Lead (DK), EU+
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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 Principal Regulatory Lead you will create and drive the regional regulatory strategy for a product(s) / project(s) and ensure there is a sound regulatory foundation for the successful optimization of the product /project in accordance with business priorities working closely with local RA and/or regional cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on global strategy.
- Primary RA representative and responsible to their region in relation to overall project strategy including pre-clinical and clinical (working with local RA where required)
- Responsible for the regional regulatory strategy by liaising with local RA to ensure alignment with regional and global commercial plans and priorities to optimize portfolio
- Responsible for regulatory interactions, and submissions, with strategic accountability for the regional filings while leveraging their GRT subject matter experts and endorsed by GRT
- Train, act as mentor and ensure proactive communication and knowledge sharing of strategic regulatory topics with GRT and other relevant stakeholders
- Act as subject matter expert, as applicable. • Challenge and improve existing procedures
- Review relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance / legislation, as applicable, while leveraging GRT subject matter expertise
- Manage coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs) for their region, working in a global collaborative manner. Ensure timely follow up and execution according to agreed timelines
The ideal candidate will maintain expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations including Competitor 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/LCM teams (as relevant) and region of responsibility. She/he will act pro-actively and sustain a good stakeholder collaboration within GRA and in LEO organization via continuous stakeholder management. Represent GRA according to delegated tasks and will provide budget input for regional plans.
The role can be based in Denmark, Norway, Sweden, Ireland and UK.
Your qualifications
We are looking for a team player and pioneer with a strategic global mindset, who can see opportunities and possible solutions when facing tough challenges. You know how to develop team members through coaching and feedback. You have strong and effective stakeholder management skills, and you have the persistence to keep on going. You are proactive and curious with the ability to find the most feasible regulatory pathway. You think locally and act globally – and you think globally and act locally. Your professional skillset comprises:
- Master's or bachelor's degree within natural science or equivalent. Advanced degree preferred
- 10+ years pharmaceutical industry and relevant local and/or global strategic regulatory experience, including leading achievement of major regulatory milestones. Solid experience of the regulatory framework on a global level from both development- and life cycle management phases of drug development with increasing complexity
- Advanced understanding of the entire drug development/LCM process and how the development/LCM program and needed Health Authority interactions/filings/label
- Expert regional regulatory guideline, requirements and precedence to inform strategic regional considerations
- Regional business acumen
Your new team
You will join a team of at least three skilled and dedicated regulatory strategists. We are responsible for creating and driving regulatory strategies for successful optimization of product /project in accordance with business priorities. We are based at the LEO headquarters in Ballerup, Greater Copenhagen and in Madison, NJ USA
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application If you have questions, please do not hesitate to contact Antonella Lozito-Heerschap, Head of Global Regulatory Strategy, Global Regulatory Strategy - Innovativ - [email protected]
. The deadline is November 15th 2020.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 5.10.2020, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- København
- Søndag den 15. november 2020
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