ID1046
Principal Advisor Pharma Development
MSc. Pharmacy, Copenhagen University
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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More than 30 years of experience from the pharmaceutical industry hereof 14 years’ experience from RA CMC.
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RA CMC experience with CMC strategies for injectables and solid dosage form development and marketing authorizations wordwide (EU/US/JP/CA/Australia/China).
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Seven years of managerial experience within RA CMC.
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Experience with writing of CTA/INDs for clinical trial applications for Phase I-III.
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Experience with Q&A phases for CTA/IND/NDA/BLA/MAA approvals.
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RA CMC experience with CMC strategies for LCM changes.
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10 years of experience with product development (injectables and solid dosage forms) for early development and MAA/BLA.
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Experience from clinical development including GCP training.
Key results
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Successful review of BLA/MAA resulting in approval of Skytrofa (Nonapegsomatropin) in EU/US.
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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®.
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Successful submission and approval of INDs/CTAs for projects in phase I and phase II.
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Timely and successful NDA submission and approval of PrandiMet® in China and Israel.
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Hands on experience with Decentralised and Centralised regulatory procedures in EU.
Software/Standards
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ICH Q1 to Q12 covering regulatory requirements for NCE and Biologics (Medicademy Module 6 and 10).
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The Regulatory law frame in EU (Module 1 and 2 Medicademy).
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The Regulatory Environment in JP (Module 4 Medicademy).
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21 CFR including guidelines for INDs/NDAs, BLAs and Supplements.
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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.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com