Ulrikke Lynge Jensen
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 Regulatory Affairs for human as well as veterinary medicinal products and 5 years experience with QA.
- - 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.