Ulrikke Lynge Jensen

Ulrikke Lynge Jensen
M.Sc.Pharm., Director & Owner

Ulrikke Lynge Jensen is M.Sc. Pharmacy and has been with Billev Pharma since March 2008. 1 May 2011 Ulrikke Lynge Jensen became partner in Billev Pharma and in May 2015 she took over the position as Managing Director together with Anja van Arkens.

She has more than 10 years experience with QA and with Regulatory Affairs for human as well as veterinary medicinal products.  

  • 6 years experience as a Specialist and Head of Section at a Global Danish Pharmaceutical Company handling procedures within and outside the EU.
  • Experience with Regulatory Affairs from a subsidiary handling requirements from the Nordic countries.
  • Wide experience with maintenance activities for both human and veterinary medicinal products, initial procedures for veterinary medicinal products and with compilation of electronic submissions (eCTD, NeeS and VNeeS).
  • Trained Responsible Person (GDP) and lead GDP auditor.
  • Trained and authorised Qualified Person (GMP) for smaller companies. Experience with GMP audits and inspections.
  • Has participated in different project groups focusing on the implementation of regulatory requirements in production and QC department and on interaction areas with Regulatory Affairs.
  • Experience with the implementation of electronic submission software, electronic archiving systems for regulatory documents and information.
  • Speaker at international and national seminars on electronic submissions.
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...