Charlotte Munk Ejlersen

Charlotte Munk Ejlersen
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

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...

Dyrlæger i life science

I det nyeste nummer af Pharma kan du læse om vores kollega Charlotte Lindorf Eriksen og hendes arbejde med pharmacovigilance som dyrlæge i Billev Pharma Pharma nr. 3 2023—Side 14 (ipaper.io). Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...