Senior Regional Regulatory Lead (DK), EU+
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
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
Lignende jobs
-
Restaurant Manager, Restaurant Ansvar at Scandic S...
Fri kontaktJob Description. If you are ambitious, goal-oriented and not afraid to clear habitual thinking off the table, then we believe that you are our new Restaurant Manager for Restaurant Ansvar, Scandic Spectrum. We know that you take responsibility and have peace of mind with the full overview.Få mere info- Øvrige
- København
-
Restaurant Manager til Restaurant Ansvar, Scandic ...
Fri kontaktEr du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Restaurant Manager til Restaurant Ansvar, Scandic Spectrum. Vi ved, at du ta’r ansvar og har ro i maven med det fulde overblik. Du er god til at organisere, købe ind, lede og dele din viden.Få mere info- Øvrige
- København
-
Conference Host, fuldtid, Scandic Sluseholmen
Fri kontaktGriber du mulighederne, har overblik og er god til at guide vores gæster, så tror vi på, at du er vores nye Conference Host på Scandic Slusenholmen. Vi ved, at du brænder for at gøre en forskel og har fokus på detaljerne. Og vi ved, at du får tingene til at ske og gerne sætter overliggeren lidt højere for at skabe en succes.Få mere info- Øvrige
- København
Statistik over udbudte jobs som øvrige i København
Herunder ser du udviklingen i udbudte øvrige i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige i København.
Se flere statistikker her:
Statistik over udbudte øvrige i København over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 4. november 2024 | 906 |
| 3. november 2024 | 920 |
| 2. november 2024 | 930 |
| 1. november 2024 | 945 |
| 31. oktober 2024 | 958 |
| 30. oktober 2024 | 949 |
| 29. oktober 2024 | 953 |
| 28. oktober 2024 | 942 |
| 27. oktober 2024 | 964 |
| 26. oktober 2024 | 974 |
| 25. oktober 2024 | 881 |
| 24. oktober 2024 | 927 |
| 23. oktober 2024 | 1021 |
| 22. oktober 2024 | 1020 |
| 21. oktober 2024 | 1041 |
| 20. oktober 2024 | 1104 |
| 19. oktober 2024 | 1117 |
| 18. oktober 2024 | 1082 |
| 17. oktober 2024 | 1076 |
| 16. oktober 2024 | 1074 |
| 15. oktober 2024 | 996 |
| 14. oktober 2024 | 969 |
| 13. oktober 2024 | 993 |
| 12. oktober 2024 | 987 |
| 11. oktober 2024 | 999 |
| 10. oktober 2024 | 984 |
| 9. oktober 2024 | 961 |
| 8. oktober 2024 | 954 |
| 7. oktober 2024 | 941 |
| 6. oktober 2024 | 953 |
| 5. oktober 2024 | 936 |
Værd at vide når du søger job som øvrige i København
Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.
Bydele i København
København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:
Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.
Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.
Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.
Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.
Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.
Find ledige jobs i Valby
Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.
Mere information om København
Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer