Senior 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 Senior Regional Regulatory Lead your overall objectives is to 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 via the GRT.
- 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
- 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. You 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 the following countries: Denmark, Norway, Sweden, Ireland and UK.
Your qualifications
We are looking for a team player and pioneer with a global mindset, who can see opportunities and possible solutions when facing tough challenges. 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 or degree within natural science or equivalent
- Seniority within regulatory +5 years, with primary responsibility of having achieved major local regulatory milestones, including drug development milestones (e.g., pre-IND, National Advice) and/or life cycle management milestones (e.g., line extensions)
- Broad business understanding and knowing the business and the impact of the project
- Advanced understanding of the entire drug development/LCM process and how the development/LCM program and needed Health Authority interactions/filings/label
- Understanding of science and data relevant for development and LCM
- Expert regional regulatory guideline, requirements and precedence to inform strategic regional considerations
- Regional business acumen
Your new team
You will join a small but dedicated and skilled 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.
Contact and application
If you have questions, please do not hesitate to contact Sheetal Alur, Senior Global Regulatory Lead, Global Regulatory Strategy - Innovativ [email protected]
. The deadline for application is February 14th 2021.
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 14. februar 2021
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