Alexander Striebeck, PhD

I have seven years of regulatory affairs experience in the pharmaceutical and food industry and a strong scientific background. For me, it is a pleasure to handle multiple projects at once, listening to experts for their input and sharing my knowledge with stakeholders. I enjoy to improve processes, ideally using digital solutions and need to be intellectually stretched to grow professionally. My colleagues describe me as analytical, dedicated, down-to-earth realist, organised and unpretentious.

Professional experience

Senior Regulatory Professional

Novo Nordisk, Denmark, January 2023–Present

Leading the migration of regulatory documents for four full company acquisitions as well as five product acquisitions
Cross-functional project and stakeholder management within Development (Regulatory, Clinical Operations, Safety), Research & Early Development (Global Drug Discovery) and CMC
Development of guidelines for the smooth and effective migration of new acquisitions into Veeva Vault RIM
Planning and facilitating processes and projects to enable Regulatory Affairs to work with new products in Vault RIM
Management of regulatory activities across the entire product portfolio
Automation of data and document migration using Python
Trained Vault RIM Business Administrator

Senior Regulatory Professional

Novozymes (now Novonesis), Denmark, January 2021–December 2022

Regulatory stakeholder for two food enzyme product categories
Core group member of product development projects, with the focus on the development of regulatory strategies for the successful assessment of products by international authorities, including authority interactions
Submission management of regulatory document packages in the European Union; coordination of and support for global submissions, including South East Asia/Oceania, South Korea, China, the Americas together with local colleagues
Close collaboration with Novozymes’ Strain Approval Support (SAS) team
Core group member of a project for a new Regulatory Information Management system based on the Veeva platform
Customer relationship management for customers

Regulatory Affairs Specialist

Novozymes (now Novonesis), Denmark, November 2017–December 2020

Regulatory stakeholder for one food enzyme product category, core group member of product development projects, customer relationship management and submission of regulatory document packages in the EU
Coordination of and support for submissions in Australia/New Zealand, Japan and South Korea with local colleagues

Post Doc, Scientist

Carlsberg Research Laboratory, Denmark, July 2013–October 2017

Core group member in a project focused on improving brewing technologies
Biochemical characterisation of enzymes involved in the formation and degradation of starch
Recombinant gene expression, small-scale protein purification; binding assays; biochemical characterisation, including the development of enzyme assays; protein crystallisation and determination of the 3D structure of plant enzymes

Research Assistant

University of Dundee, Scotland, April 2013–June 2013

Recombinant gene expression and purification of human proteins

Technician

University of Dundee, Scotland, January 2009–March 2009

Performing routine tasks to provide support for the work group

Education

PhD

University of Dundee, Scotland, April 2009–March 2013

Thesis Structural and biochemical characterisation of enzymes involved in mannan biosynthesis
Recombinant gene expression, small-scale protein purification; biochemical characterisation, including the development of enzyme assays; protein crystallisation and determination of the 3D structure of a fungal and bacterial enzyme

MSc Biotechnology

FH Lausitz, Germany, March 2007–December 2008

Thesis Biogenesis of small nuclear ribonucleoprotein particles in the absence of Cajal bodies; conducted at Max Planck Institute for Molecular Cell Biology and Genetics, Germany (Neugebauer group)
Recombinant gene expression in human cell culture cells; characterisation of RNA molecules by northern blotting

BSc Biotechnology

FH Lausitz, Germany, September 2003–February 2007

Thesis Biochemical and molecular biological characterisation of the sperm head protein calicin in tissue culture cells and interaction with other sperm proteins; conducted at German Cancer Research Center, Germany (Franke group)
August 2005–January 2006: Practical term with final report Expression of Nuclear Transcriptional Co-Regulators Throughout Mammary Epithelial Cell Differentiation; conducted at NOVUM Karolinska Institute (Haldosén group), Sweden
Recombinant gene expression in human cell culture cells; protein purification and characterisation, including SDS-PAGE and western blotting

Skills

Project management

Stakeholder management across multiple internal functions and external assets
Coordination of characterisation studies for new enzyme projects, including biochemical, performance, safety and toxicological analyses in cross-functional teams and with external partners
Delivery of data to global regulatory stakeholders for the timely submission of documentation for approval of new enzyme products
Mitigation of questions of competent authorities together with cross-functional stakeholders

Science

Biochemistry, e.g. SDS-PAGE, Western blot, chromatography, enzyme assay development
Molecular biology, e.g. cloning into E. coli and yeasts, Northern blot
Microbiology, e.g. heterologous expression in bacteria and yeasts
X-ray crystallography
Cell culture, e.g lipotransfection, 2-D and 3-D culturing, immunocyto- and histochemistry
Automation/Instrument control, e.g. fundamental knowledge of TECAN robots operation and scripting, National Instruments LabView

Communication

Customer relationship management of global customers via mail, video conferencing or in person
Touchpoint with competent authorities via mail or in person
Strong presentation and educational skills due to presentations at international conferences, hosting workshops, tutorials and public engagement events

Digial competence

Operating systems: Apple macOS, Microsoft Windows, Linux
Other: Microsoft Office, Microsoft SharePoint
Regulatory Management: Veeva Vault RIM (Business Administrator)
Database systems: Microsoft Access, MySQL
Programming languages: Python (intermediate)

Publications

Scientific articles

Knudsen S, Wendt T, Dockter C, Thomsen HC, Rasmussen M, Jørgensen ME, Lu Q, Voss C, Murozuka E, Østerberg JT, Harholt J, Braumann I, Cuesta-Seijo JA, Kale SM, Bodevin S, Petersen LT, Carciofi M, Pedas PR, Husum JO, Nielsen MTS, Nielsen K, Jensen MK, Møller LA, Gojkovic Z, Striebeck A, Lengeler K, Fennessy RT, Katz M, Sanchez RG, Solodovnikova N, Förster J, Olsen O, Møller BL, Fincher GB, Skadhauge B. FIND-IT: Accelerated trait development for a green evolution. Science Advances. 2022 Aug 24;8(34):eabq2266. doi: 10.1126/sciadv.abq2266
Cuesta-Seijo JA, De Porcellinis AJ, Valente AHR, Striebeck A, Voss C, Marri L, Hansson A, Jansson AM, Dinesen MH, Fangel JU, Harholt J, Popovic M, Thieme M, Hochmuth A, Zeeman SC, Mikkelsen TNR, Jï Rgensen RB, Roitsch TG, Mï Ller BL, Braumann I. Amylopectin Chain Length Dynamics and Activity Signatures of Key Carbon Metabolic Enzymes Highlight Early Maturation as Culprit for Yield Reduction of Barley Endosperm Starch after Heat Stress. Plant Cell Physiol. 2019 Dec 1;60(12):2692-2706. doi: 10.1093/pcp/pcz155
Nielsen MM, Ruzanski C, Krucewicz K, Striebeck A, Cenci U, Ball SG, Palcic MM, Cuesta-Seijo JA. Crystal Structures of the Catalytic Domain of Arabidopsis thaliana Starch Synthase IV, of Granule Bound Starch Synthase From CLg1 and of Granule Bound Starch Synthase I of Cyanophora paradoxa Illustrate Substrate Recognition in Starch Synthases. Front Plant Sci. 2018 Aug 3;9:1138. doi: 10.3389/fpls.2018.01138
Kadouche D, Ducatez M, Cenci U, Tirtiaux C, Suzuki E, Nakamura Y, Putaux JL, Terrasson AD, Diaz-Troya S, Florencio FJ, Arias MC, Striebeck A, Palcic M, Ball SG, Colleoni C. Characterization of Function of the GlgA2 Glycogen/Starch Synthase in Cyanobacterium sp. Clg1 Highlights Convergent Evolution of Glycogen Metabolism into Starch Granule Aggregation. Plant Physiol. 2016 Jul;171(3):1879-92. doi: 10.1104/pp.16.00049. Epub 2016 May 19
Cuesta-Seijo JA, Nielsen MM, Ruzanski C, Krucewicz K, Beeren SR, Rydhal MG, Yoshimura Y, Striebeck A, Motawia MS, Willats WG, Palcic MM. In vitro Biochemical Characterization of All Barley Endosperm Starch Synthases. Front Plant Sci. 2016 Jan 28;6:1265. doi: 10.3389/fpls.2015.01265
Wang S, Cuesta-Seijo JA, Striebeck A, Lafont D, Palcic MM, Vidal S. Design of Glycosyltransferase Inhibitors: Serine Analogues as Pyrophosphate Surrogates? Chempluschem. 2015 Oct;80(10):1525-1532. doi: 10.1002/cplu.201500282. Epub 2015 Jul 14
Striebeck A, Robinson DA, Schüttelkopf AW, van Aalten DM. Yeast Mnn9 is both a priming glycosyltransferase and an allosteric activator of mannan biosynthesis. Open Biol. 2013 Sep 11;3(9):130022. doi: 10.1098/rsob.130022

Patents

Barley plants with high limit dextrinase activity (EP4114170)
Method to screen for a mutant within a population of organisms by applying a pooling and splitting approach (EP3478832)

Protein structures

Catalytic domain of Starch Synthase IV from Arabidopsis thaliana bound to ADP and acarbose (PDB 6GNE)
AAGlyB in complex with amino-acid analogues (PDBs 4Y62, 4Y63, 4Y64)
Crystal structure of Bacillus circulans TN-31 Aman6 (in complex with mannobiose) (PDBs 4BOK, 4BOJ)
Crystal structure of Saccharomyces cerevisiae Mnn9 in complex with GDP and Mn (PDB 3ZF8)

Languages

German, native
English, fluent
Danish, fluent

Interests

Photography and photo editing
Cycling, running, volleyball
Programming
Baking breads and cakes

31 March 2025