Regulatory Affairs Specialist
Current• Lifecycle management variations • Ensuring compliance with EU/ local regulations• Marketing authorisation transfer submissions
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Marko Krajnc is listed as Regulatory Affairs Specialist at Takeda I Co-founder of ExpAR at Takeda, a with 32621 employees, based in Ljubljana, Slovenia. AeroLeads shows a matched LinkedIn profile for Marko Krajnc.
Marko Krajnc previously worked as Regulatory Affairs Specialist at Takeda and Co-Founder and Product Owner at Linking Map. Marko Krajnc holds Bachelor'S Degree, Microbiology from University Of Ljubljana, Biotechnical Faculty.
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Enthusiastic about designing unique user experience solutions. Committed to innovating in the field of Sustainable development.Specialties:Regulatory Affairs, Business Analytics, PM, PLM, QA Management,Fields of Interest:UX/UI Design, Sustainability transformation, Agile, Innovative business models, Business Intelligence.đź’ˇ "As the Zen Buddhist saying goes, how you do anything is how you do everything." - Simon Sinek
Listed skills include Biotechnology, Product Management, Microbiology, Lifesciences, and 30 others.
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A career timeline built from the work history available for this profile.
Ljubljana, Slovenia
• Lifecycle management variations • Ensuring compliance with EU/ local regulations• Marketing authorisation transfer submissions
Ljubljana, Slovenia
We support organizations to optimize all resources for efficient operations and we connect and coordinate sustainable business transformation across organizations.• Optimising all resources for efficient business operations• Managing business transformation• Enabling symbiosis of sustainable business• Providing complete digital solutions for Industry 4.0• Equipping organizations for future-proof business
Ĺ martno V RoĹľni Dolini, Slovenia
Co-founder of local organic family farm:• growing apples, peaches and hazelnuts• certified activity (eco-farming certificate nr. 28819)• involved in community distribution initiatives• Web and product design
Ljubljana, Slovenia
• Business Analysis / preparing Business Case with strategic analysis• Project planning, project implementation, progress & cost control, and project closure• Assembling and coordinating project team members, SCRUM master• Definition and implementation of harmonized project's KPIs• UX/UI design, prototyping, information architecture design, user testing
Cesta V Mestni Log 88A, Si-1000 Ljubljana
• Preparing documentation for registration of food supplements on clients local markets (40+ countries worldwide)• Consulting regarding regulatory requirements• Coordinating documents legalization processes• Revision of ArtworksOther:• Business analytics & BPM for in-house software development: prepare requirements, user testing, moderate weekly team meetings.
Cesta V Mestni Log 88A, 1000 Ljubljana
QC/QA • Designing and coordinating stability studies • Preparing QC internal documents and formulars• Implemenation of ISO 9001:2008• Communicating with external laboratories, suppliers regarding QC issuesRegulatory Affairs• Ensuring Regulatory compliance with the current legislation (EU, local)• Working with local regulatory agencies and personnel on specific issues• Advising our clients on the regulatory aspects when launching a productExhibition Coordination and Management• Planning and budgeting, track payments and deadlines• Communication with the organizer (preparing the documentation)• Coordinating activities with outside contractor for stand design• Procurement of materials to be used in exhibitions and installations, ordering materials, and negotiate costs with vendors• Post exhibition activities (negotiation for next year location, lead management)Registration• Preparing documentation for company / product registrations on EU / non-EU markets.• Coordinating documents legalization processesStrategic Sourcing• Vendor Management• Price negotiation• Market Research - analyze new opportunities and developments• Identify cost reduction strategies• Establish new strategic relationships with top rated suppliersBusiness or sector: Dietary Supplements, Functional Foods, Food & Beverages
Valjhunova 11, 1000 Ljubljana
▪ Market Research analysis▪ Managing Sales Leads• Client support• Arranging and conducting sales meetings• Preparing offers and marketing materials• Website Content Marketing• Maintaining Web designBusiness or sector: Dietary Supplements, Functional Foods, Food & Beverages
Ulica Xiv. Divizije 12, 3000 Celje, Slovenia (Eu)
As a Participant in Operation "Podjetno v svet podjetništva 2013 (PVSP)" I was working on my business idea, attending different training courses to improve Entrepreneurial Skills and wrote a business plan.Business or sector: Product Development & Sales, Public sector
Toplarniška 19, Si-1000 Ljubljana, Slovenia (Eu)
â–Ş Setting up a protocol of cooperation and coordination of logistics for transportation of biological samplesâ–Ş Designing brochures, flyers, other presentation materials â–Ş Identification of potential clientsâ–Ş Presentation of services to potential clientsâ–Ş Marketing activities to promote sales at our contact partnersBusiness or sector: Biotechnology, Functional Medical Diagnostics
Toplarniska 19, Si-1000 Ljubljana
â–Ş Product Designâ–Ş Implementing QA system (designing tailored made LIS)â–Ş Regulatory Affairs (preparation of documents for work permit)â–Ş PLM (designing protocols, forms, record sheets and implementation of diagnostic services in routine laboratory work at the Institute (Salivary Hormone Testing, Personalized functional diagnostic panels for the target group of customers)â–Ş Carrying out routine diagnostic tests and Work Flow Optimizationâ–Ş Sales activities, introduction to potential clients, preparing PR materialsBusiness or sector: Biotechnology, Functional Medical Diagnostics
Toplarniska 19
â–Ş Product Design (services of Institute)â–Ş Market Research analysis (segmentation and identification of the target groups of potential clients)â–Ş Preparing presentations and other PR materialsâ–Ş Sales Presentations to potential clientsâ–Ş Independent coordination, implementation of commercial projectsâ–Ş Presentation of results to customerâ–Ş Writing a business planâ–Ş Preparation of tender documentsBusiness or sector: Biotechnology, Molecular Microbiology
Ptujska 21, Si-1000 Ljubljana, Slovenia
â–Ş Preparing samples for HPLC analysisâ–Ş Carry out different independent studies of stability of medicinesâ–Ş Administrative tasksBusiness or sector: Analytical Chemistry, Public sector
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James Downey
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Celina Korsgaard Heiberg
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Lilia Benzina
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Caiolfhionn Eccles
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Jake Myers
Colleague at TakedaWaukegan, Illinois, United States
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Nathalie Van Damme
Colleague at TakedaDĂĽbendorf, Zurich, Switzerland
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Ricardo Palma MunguĂa
Colleague at TakedaCoyoacán, Mexico City, Mexico
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Sharon O Connor
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Jenny Silzle Ford
Colleague at TakedaGreater Philadelphia, United States
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Graduated in Microbiology at Biotechnical Faculty, University of Ljubljana. Bachelor year specialized in Microbial ecology.
EU Erasmus + Programme on Sustainability Leadership. Analysis of good practices and courses for sustainability and leadership skills.
Quick answers generated from the profile data available on this page.
Marko Krajnc works for Takeda.
Marko Krajnc is listed as Regulatory Affairs Specialist at Takeda I Co-founder of ExpAR at Takeda.
Marko Krajnc is based in Ljubljana, Slovenia while working with Takeda.
Marko Krajnc has worked for Takeda, Linking Map, Hriberšek, Freelance, and Pharmalinea.
Marko Krajnc's colleagues at Takeda include Yosuke Nakano, James Downey, Celina Korsgaard Heiberg, Lilia Benzina, and Caiolfhionn Eccles.
You can use AeroLeads to view verified contact signals for Marko Krajnc at Takeda, including work email, phone, and LinkedIn data when available.
Marko Krajnc holds Bachelor'S Degree, Microbiology from University Of Ljubljana, Biotechnical Faculty.
Marko Krajnc is listed with skills including Biotechnology, Product Management, Microbiology, Lifesciences, Molecular Biology, Product Marketing, Biochemistry, and Genomics.
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