Regulatory Affairs-koordinator
24 hours ago
Vil du gøre en reel forskel for tilgængeligheden af lægemidler i det danske sundhedsvæsen og bringe alle dine regulatoriske kompetencer i spil? Så er du måske vores nye Regulatory Affairs-koordinator hos Epione Medicine, hvor vi søger en dedikeret kollega til vores RA-afdeling.
Om stillingenSom Regulatory Affairs-koordinator i Epione Medicine vil du være med til at sikre markedsføring af over 100 forskellige lægemidler, som vi distribuerer til det danske sundhedsvæsen, samt lancering af nye produkter.
I rollen som Regulatory Affairs-koordinator er du ansvarlig for at udarbejde og indsende ansøgninger på nye lægemidler samt vedligeholde dokumentationen for lancerede produkter.
Du vil arbejde tæt sammen med kollegaer fra forretningsudvikling, indkøb, kvalitet og produktion.
Dine arbejdsopgaverUdarbejdelse af materiale til ansøgning om markedsføringstilladelse
Opsætning og korrekturlæsning af indlægssedler og tekster til pakkemateriale
Besvarelse af spørgsmål fra myndigheder vedrørende ansøgninger
Life cycle management af lancerede produkter
Udarbejdelse af materiale til variationsansøgninger
Koordinering af produktspecifikke ændringssager (Change Controls)
Monitorering og implementering af dansk og europæisk lovgivning
Support til kollegaer med produktspecifikke RA-oplysninger og dokumentation
Support af QA-opgaver som batchgennemgang, afvigelser, opdatering af SOP’er og træning af medarbejder i GDP & GMP.
Du bliver en del af et professionelt, hurtigt voksende og ambitiøst scale-up-miljø, hvor der er kort afstand fra tanke til handling, og hvor vi samarbejder tæt med både interne og eksterne interessenter. Du vil få en central rolle i en spændende vækstfase, der indebærer stor udvikling af vores produktportefølje og regulatoriske projekter.
Vores kontor, lager og produktion er beliggende på Avedøre Holme, kun 10 km fra København.
PraktiskArbejdstid: Fuld tid
Tiltrædelse: Hurtigst muligt
Fleksible arbejdstider, hvor du primært skal være tilgængelig mellem kl. 09-15, med mulighed for hjemmearbejde
Løn og vilkår: Efter kvalifikationer med attraktive ansættelsesforhold
Du har en bachelor- eller erhvervsfaglig uddannelse med sundhedsfaglig specialisering men andre uddannelser kan også være relevante. Det er en fordel, hvis du har erfaring med regulatoriske arbejdsopgaver, men vigtigst af alt skal du have interesse for opgaverne. Derudover lægger vi vægt på følgende kvalifikationer:
Evnen til at fokusere på detaljer uden at miste overblikket
Du er fagligt dedikeret, men med et kommercielt mindset
Evne til at koordinere flere arbejdsopgaver på én gang
Erfaring med regulatorisk arbejde
Kan kommunikere flydende på dansk og engelsk
Flair for IT – gerne Word og Adobe
Det er væsentligt, at du har en høj arbejdsmoral og er nysgerrig på at forstå det danske sundhedssystem med fokus på distribution af lægemidler. Endelig skal du kunne arbejde i et til tider travlt arbejdsmiljø og bidrage til et godt humør.
Epione Medicine som arbejdspladsEpione Medicine leverer medicin til det danske sundhedsvæsen. Vores produkter parallelimporteres fra certificerede grossister i EU-lande og sælges i Danmark under de samme betingelser som de originale producenter. Vi er en ambitiøs scale-up-virksomhed, der blev etableret i 2020, og vi tæller i dag 25 medarbejdere. Dette giver dig mulighed for at tage et stort ansvar og sætte dit præg på forretningen inden for dit arbejdsområde.
Ansøgningsfrist31. januar 2025.
Ansøgninger vil blive gennemgået løbende, og samtaler vil blive afholdt herefter.
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