M.Sc. Pharm., Senior Regulatory Affairs Manager
Mette Clausen is M.Sc. in Pharmacy and has been with Billev Pharma since September 2025 as Senior Regulatory Affairs Manager. Mette’s experience covers:
- 25+ years of experience within regulatory affairs including 7 years as biological assessor at the Danish Medicines Agency and 18+ years from Global Danish Pharmaceutical and Biotech companies working as Regulatory CMC specialist in the field of drugs/biologicals/bio-pharmaceuticals and drug-device combination products
- Wide experience with CMC and device requirements for clinical trials and marketing authorization application in Europa and US
- Experience with both human and veterinary medicinal products
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
Latest News
Vi søger erfaren Pharmacovigilance Specialist – Stillingen er besat
Har du erfaring med pharmacovigilance - og søger du spændende arbejdsopgaver og stor fleksibilitet i din hverdag? Så er du måske den kollega, vi leder efter! Hos Billev Pharma ApS tilbyder vi en spændende mulighed for at arbejde med avancerede PV-opgaver på...
Vi søger erfaren CMC-specialist – Stillingen er besat
Er du ekspert i RA CMC og søger du spændende arbejdsopgaver og fleksibilitet i din hverdag? Så er du måske den kollega, vi leder efter! Hos Billev Pharma ApS tilbyder vi en spændende mulighed for at arbejde med avanceret farmaceutisk og analytisk regulatorisk...
En inspirerende teamdag
Hvordan kan det være, at nogle ser begyndelser (bryllup), mens andre ser slutninger (begravelse), når 4 sorte limousiner kommer kørende i kortege på tværs af vejen? Kan du lære at holde hovedet, håbet, humøret & modet oppe? JA, vi nåede 9 opbyggelige øvelser på 5...