EU+ Regulatory Lead, Global Regulatory Strategy, Innovative Portfolio
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Ballerup
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. Create and drive regional regulatory strategy for a product to enable business priorities working closely with local and regional stakeholders (e.g., medical, marketing, market access).
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 overall objective for this position is to create and drive regional regulatory strategy for a product in alignment with global regulatory strategy. Specifically, the position’s responsibilities include:
You will join a team of skilled, dedicated regulatory professionals. Working with the Global Regulatory Team of 8 team members providing regulatory support and driving activities for a late-stage asset. The preferred location for this position is at the LEO Pharma HQ in Ballerup, Greater Copenhagen or, for the right candidate it might be possible to work from any LEO office in Europe.
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.
If you have questions, please do not hesitate to contact Lisa R. Pruss, Senior Director, Global Regulatory Lead, Innovative Portfolio at +1 973-796-7024.
. The deadline is 4th of April 2022, however interviews will be conducted on an ongoing basis.
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.
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
The overall objective for this position is to create and drive regional regulatory strategy for a product in alignment with global regulatory strategy. Specifically, the position’s responsibilities include:
- Primary RA representative and responsible for their region in relation to overall project strategy including pre-clinical and clinical (working with local RA where required).
- Development of regional regulatory strategy while ensuring alignment with commercial plans and priorities.
- Development of strategy for, and execution of, regulatory interactions with regional Health Authorities
- Defining content for regional submissions, with strategic accountability for ensuring high quality and timely submissions and approvals.
- 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.
- 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 on European regulatory procedures, as applicable.
- Maintain expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations including competitor intelligence/landscape.
- Provide clear and valid regulatory guidance, interpretation by applying ‘out of the box thinking’ mind set, direction to GRT and region of responsibility.
- 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.
- Provide budget input for regions plans
Your qualifications
- Masters 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.
- Advanced understanding of the entire drug development/LCM process and how the development/LCM program and needed Health Authority interactions impact label.
- Expert understanding of regional regulatory guidelines, requirements and precedence to inform strategic regional considerations
- Regional business acumen
Competency expectations of the individual in the position are as follows:
- Strategic mindset with a curious and alternative mindset.
- Proactive thinking and a ‘yes-can-do’ attitude.
- Develop team members through coaching and feedback.
- Team player.
- Communication/sharing information to secure ‘One GRA voice’.
- Personal drive, positive attitude and high level of commitment.
- Broad business understanding and knowing the business and the impact of the project.
Your new team
You will join a team of skilled, dedicated regulatory professionals. Working with the Global Regulatory Team of 8 team members providing regulatory support and driving activities for a late-stage asset. The preferred location for this position is at the LEO Pharma HQ in Ballerup, Greater Copenhagen or, for the right candidate it might be possible to work from any LEO office in Europe.
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 Lisa R. Pruss, Senior Director, Global Regulatory Lead, Innovative Portfolio at +1 973-796-7024.
. The deadline is 4th of April 2022, however interviews will be conducted on an ongoing basis.
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 Ballerup.
Jobbet er oprettet på vores service den 3.3.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
- Mandag den 04. april 2022
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Statistik over udbudte øvrige i Ballerup over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 22. november 2024 | 49 |
| 21. november 2024 | 57 |
| 20. november 2024 | 56 |
| 19. november 2024 | 52 |
| 18. november 2024 | 53 |
| 17. november 2024 | 55 |
| 16. november 2024 | 56 |
| 15. november 2024 | 61 |
| 14. november 2024 | 61 |
| 13. november 2024 | 60 |
| 12. november 2024 | 59 |
| 11. november 2024 | 61 |
| 10. november 2024 | 61 |
| 9. november 2024 | 61 |
| 8. november 2024 | 59 |
| 7. november 2024 | 56 |
| 6. november 2024 | 57 |
| 5. november 2024 | 57 |
| 4. november 2024 | 56 |
| 3. november 2024 | 60 |
| 2. november 2024 | 59 |
| 1. november 2024 | 59 |
| 31. oktober 2024 | 76 |
| 30. oktober 2024 | 76 |
| 29. oktober 2024 | 82 |
| 28. oktober 2024 | 85 |
| 27. oktober 2024 | 86 |
| 26. oktober 2024 | 85 |
| 25. oktober 2024 | 77 |
| 24. oktober 2024 | 78 |
| 23. oktober 2024 | 82 |