Principal Advisor Pharma Development

MSc. Pharmacy, Copenhagen University
Available for: Part-time, full-time, tasks

Contact us for full CV


  • More than 30 years of experience from the pharmaceutical industry hereof 14 years’ experience from RA CMC.

  • RA CMC experience with CMC strategies for injectables and solid dosage form development and marketing authorizations wordwide (EU/US/JP/CA/Australia/China).

  • Seven years of managerial experience within RA CMC.

  • Experience with writing of CTA/INDs for clinical trial applications for Phase I-III.

  • Experience with Q&A phases for CTA/IND/NDA/BLA/MAA approvals.

  • RA CMC experience with CMC strategies for LCM changes.

  • 10 years of experience with product development (injectables and solid dosage forms) for early development and MAA/BLA.

  • Experience from clinical development including GCP training.

Key results

  • Successful review of BLA/MAA resulting in approval of Skytrofa (Nonapegsomatropin) in EU/US.

  • Successful review of BLAs/MAAs resulting in approval of Refixia®(Nonacogbetapegol) and Esperoct® (turoctocogalfapegol)
    Development of challenging regulatory strategies and risk analysis for meeting packages and responses submitted during review of BLAs/MAAs and substantial supplements.

  • Successful submission and approval of several substantial amendments worldwide for NovoEight®, NovoSeven® and NovoThirteen®.

  • Successful submission and approval of INDs/CTAs for projects in phase I and phase II.

  • Timely and successful NDA submission and approval of PrandiMet® in China and Israel.

  • Hands on experience with Decentralised and Centralised regulatory procedures in EU.


  • ICH Q1 to Q12 covering regulatory requirements for NCE and Biologics (Medicademy Module 6 and 10).

  • The Regulatory law frame in EU (Module 1 and 2 Medicademy).

  • The Regulatory Environment in JP (Module 4 Medicademy).

  • 21 CFR including guidelines for INDs/NDAs, BLAs and Supplements.

  • GCP certified – Brookwood International Academy of Healthcare Research.

Extensive knowledge in:

  • Veeva (Document handling and regulatory approvals).
  • Microsoft 365.

Personal Characteristics

With her many years of experience (+30) in the pharmaceutical industry within product development and regulatory affairs she has a very strong basis for settling strategies to the benefit of the projects within the regulatory framework.

She is a team player, goal and result oriented, dedicated with a high personal commitment to reach agreed timelines.

She has a positive attitude with changes and eager to acquire new competencies.

Furthermore, she has a good cultural understanding from collaboration with colleagues worldwide and very positive employee satisfaction evaluations from the teams managed over the years.


Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05