I enjoy being outdoor, preferable with my family in the wild Scandinavian nature or being in my new garden watching the wilderness I feed my inner Viking with a dip in the sea every morning I tend to love what I am doing and goes all in, whatever I set my mind on
Janne Jensen
Senior Regulatory Affairs Professional
Skodsborg
Summary
Dynamic regulatory affairs professional with extensive experience in navigating complex regulatory landscapes and ensuring compliance across diverse projects. Proven success in managing submissions and securing approvals through effective interdisciplinary collaboration while adapting to evolving regulatory requirements. Committed to delivering results and upholding high standards, with a strong focus on advancing innovative treatments and solutions that can transform lives by strategically guiding development through regulatory pathways.
My dedication lies in developing and delivering new treatments and solutions that can transform lives by strategically navigating development through regulatory pathways.
Overview
26
26
years of professional experience
10
10
years of post-secondary education
Work History
Senior Regulatory Affairs Professional
Novo Nordisk A/S, Rare Bleeding Disorders
01.2023 - Current
- Clinical Trial Applications: Managed and oversaw Clinical Trial Applications, Pediatric Investigation Plans (PIPs), and modifications, ensuring compliance with PIPs for new hemophilia products.
- Marketing Authorization Applications (MAAs): Submitted variations of MAAs globally, targeting markets such as the US, EU, Japan, UK, Canada, Australia, and Switzerland, with a primary focus on late-phase development.
- Real-World Evidence (RWE): Managed regulatory aspects in cross-functional collaborations to design and develop robust protocols for registry-based Post-Authorization Safety Studies (PASS) and compassionate use, ensuring adherence to relevant regulations and ethical guidelines.
- Gene Therapies: Worked with gene therapies and researched international GMO regulations related to these.
Regulatory Writer
Novo Nordisk A/S, CMC Process Development
01.2022 - 12.2022
- Investigational Medicinal Product Dossiers (Q-IMPD): Developed documentation for the quality part of an Investigational Medicinal Product Dossiers (Q-IMPD) for a clinical trial application (CTA), and authored the content for almost all CMC Module 3 (M3) documents.
- Early-Stage Development: The project was the company’s first cell therapy, making its way from bench to bed, so we were exploring new grounds very different from thManaged to ensure compliance with regulatory standards, despite the fact that the regulatory standards in the field of these ATMPs were also in a developing phase.these ATMPs were also in a developing phase
- Successful Submission: Achieved fast approval for the submission, supporting the advancement of the project to the dosing of the first patient. This milestone not only made the team incredibly proud, but also marked the first step to unlock the project's potential to revolutionize the future for people living with Parkinson's disease.
Senior Scientist, CMC Project Manager/Raw Material Coordinator
Novo Nordisk A/S, CMC Process Development
09.2013 - 12.2021
- In this role, I managed the early-phase development of the cell therapy project, also mentioned above, as Senior Scientist and CMC Project Manager. I played a key role in starting up the project, championed interdisciplinary collaboration across departments, and fostered innovation and creative problem-solving among colleagues and our academic collaboration partner, thereby shaping the project to meet future regulatory requirements. This was done in close collaboration with our Regulatory Affairs colleagues before I fully focused on regulatory submissions. During this phase, I participated in a pre-IND meeting with the FDA, focusing on CMC and trial design, as well as several preliminary meetings with the Japanese health authorities, PMDA, with a focus on PMDA's extensive requirements for raw material documentation.
- Interestingly, we also succeeded in what we believe is the “first time in history” of obtaining an exemption from the FDA's general ban on using UK-based biological starting materials (due to the risk of CJD/mad cow disease). I was responsible for all non-prion-related parts of this FDA exemption request, demonstrating our team’s ability to successfully navigate an unknown, explorative environment with challenging Q&As from the FDA. Our unstoppable team managed to circumvent the roadblocks.
Project Manager
Lundbeck A/S, Stem Cell Technology
01.2012 - 08.2013
- Early product development (Stem cells)
- Central nervous system (CNS), Alzheimer’s Disease
- Acting as a project manager fostering academic collaborations
Senior Scientist, Project Leader
Cellartis A/B
09.2007 - 12.2011
- Led an innovative project combining several state-of-the-art technologies; like early-stage 3D devices with stem cells to improve cell functionality
- Recognized for close collaborations with academic partners, bridging strengths between academia and small biotech
- Thrived in a fast-paced, high-pressure environment where every contribution counted, delivering results on time with innovative ideas and smart solutions
Visiting Fellow
Nation Institutes of Health/NCI
10.2005 - 07.2007
- Implementing human stem cell cultures, differentiating to liver cells, and pioneering new culture methods during this postdoc.
Research assistant and graduate student
University of Copenhagen, Panum Institute, Diabetes group
01.2000 - 01.2005
- Diabetes Research, PhD and extension to a research position.
Short term fellow
Harvard affiliate, Joslin Diabetes Center
11.2003 - 02.2004
- Islet Cell and Regenerative Biology, an exchange during my PhD to study islet biology in vivo.
Education
Ph.D. - Diabetes
University of Copenhagen, Panum Institute
Copenhagen 11.2000 - 02.2005
Master of Science - Cancer
University of Copenhagen
Danish Cancer Society 09.1994 - 10.2000
Skills
Regulatory strategy
References
Please contact me for references.
Interests
Software
VaultRim
Timeline
Senior Regulatory Affairs Professional
Novo Nordisk A/S, Rare Bleeding Disorders
01.2023 - Current
Regulatory Writer
Novo Nordisk A/S, CMC Process Development
01.2022 - 12.2022
Senior Scientist, CMC Project Manager/Raw Material Coordinator
Novo Nordisk A/S, CMC Process Development
09.2013 - 12.2021
Project Manager
Lundbeck A/S, Stem Cell Technology
01.2012 - 08.2013
Senior Scientist, Project Leader
Cellartis A/B
09.2007 - 12.2011
Visiting Fellow
Nation Institutes of Health/NCI
10.2005 - 07.2007
Short term fellow
Harvard affiliate, Joslin Diabetes Center
11.2003 - 02.2004
Ph.D. - Diabetes
University of Copenhagen, Panum Institute
11.2000 - 02.2005
Research assistant and graduate student
University of Copenhagen, Panum Institute, Diabetes group
01.2000 - 01.2005
Master of Science - Cancer
University of Copenhagen
09.1994 - 10.2000
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