M.Sc.Pharm., Senior Regulatory Affairs Manager
Charlotte Munk Ejlersen is M.Sc. Pharmacy and has been with Billev Pharma in the years 2007-2010 and again from October 2013 as a Regulatory Affairs Manager. As of January 2020 Charlotte has become Senior Regulatory Affairs Manager.
- She has more than 15 years of experience within regulatory affairs.
- 6 years experience as a regulatory coordinator at the Danish Medicines Agency.
- 3 years experience from Global Regulatory Affairs at a Global Danish Pharmaceutical Company.
- Wide experience with new national procedures, MRP and DCP procedures, renewals, variations, referrals and other regulatory issues.
- Experience with compilation of electronic submission (eCTD, NeeS and VNeeS).
- Former speaker at postgraduate courses for pharmacists (variations, referrals).
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
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...
Are you lacking the capacity or qualification to perform an audit?
At Billev Pharma we have a team of qualified lead auditors within GVP, VGVP, GMP and GDP. Last year our audit team conducted more than 10 remote pharmacovigilance audits and 10 onsite GDP audits of warehouses. We conduct remote and onsite audits within the EU as well...
Simple solutions in a complex PV environment
We are happily handling an increasing number of pharmacovigilance responsibilities for our clients in a complex pharmacovigilance environment. Our team of pharmacovigilance experts is now organised in three different fields – Human Accounts, Veterinary Accounts, and...