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Stanislav Vajicek, Phd is listed as Medical Governance Lead CEERJ+ at Sobi - Swedish Orphan Biovitrum AB (publ), a with 1087 employees, based in Bratislava, Slovakia. AeroLeads shows a work email signal at henkel.com and a matched LinkedIn profile for Stanislav Vajicek, Phd.
Stanislav Vajicek, Phd previously worked as Regulatory / Quality / Pharmacovigilance Manager CEE at Sobi - Swedish Orphan Biovitrum Ab (Publ) and Regulatory Affairs Principal Specialist at Baxter International Inc.. Stanislav Vajicek, Phd holds Doctor Of Philosophy - Phd, Organic Technology And Technology Of Fuels from Slovenská Technická Univerzita V Bratislave.
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AeroLeads found 1 current-domain work email signal for Stanislav Vajicek, Phd. Compare company email patterns before reaching out.
✔️Regulatory Affairs ✔️Pharmacovigilance ✔️Quality Assurance ✔️Project management ✔️Continuous improvement
Listed skills include Chemistry, Microsoft Office, Laboratory Skills, Gas Chromatography, and 33 others.
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A career timeline built from the work history available for this profile.
- Medical Governance in CEE-Russia-Japan + non-EU countries & partner markets- Coordinating the Business development projects and Geographical Expansion initiatives- Leading the internal/external audit & inspection readiness- Global IT systems champion (Aris LSMV, QASE, Veeva Vault & CRM)- Leading the Regulatory and Pharmacovigilance systems- Oversight of QMS, incl. NC/CAPA, Change management & SOP Lifecycle
Bratislava, Slovakia
- Representation of the CEE regional aspects in Regulatory, Quality and Pharmacovigilance - Rare-disease environment (immunology, onco-haematology, haemophilia, specialty care)- Coordination of registration/variation (CP) & labeling procedures- Ensuring the audit & inspection readiness - Quality management of non-conformities, CAPA, SOPs and change management- Ensuring the correct maintenance of Adverse events reports & product complaints
Bratislava, Slovakia
- Implementation of local and regional regulatory strategies - Management of marketing authorizations for drugs and medical devices - Broad portfolio in Oncology, Anaesthesia, IVT, Renal care, Acute, Advanced surgery, Nutrition- Preparation of regulatory applications to local authorities (ŠUKL, MoH, etc.)- Coordination and execution of regulatory submissions (MRP/DCP/national)- Surveillance of regulatory and compliance procedures, evaluation of current legal trends-… Show more - Implementation of local and regional regulatory strategies - Management of marketing authorizations for drugs and medical devices - Broad portfolio in Oncology, Anaesthesia, IVT, Renal care, Acute, Advanced surgery, Nutrition- Preparation of regulatory applications to local authorities (ŠUKL, MoH, etc.)- Coordination and execution of regulatory submissions (MRP/DCP/national)- Surveillance of regulatory and compliance procedures, evaluation of current legal trends- Providing regulatory advices to project teams- Labelling and advertising of products, incl. national trade compliance requirements- Revision of artworks and promotional materials for commercial use Show less
Vienna, Austria
- Building a solid Regulatory environment in Austrian Start-up project- Preparation of regulatory medical device submissions incl. 510(k), SaMD and technical files- Quality assurance acc. to ISO 13485 and 21 CFR part 820- Risk management of products and regulatory procedures acc. to FDA & EMA- Expert surveillance of product labelings and artworks- Cooperation with stakeholders and external partners
Slovak Republic
- Classification of products against trade requirements of government agencies - ŠUKL, MoH- Market access management activities in region of Central and Eastern Europe- License management of Merck & Sigma-Aldrich - IVD, Medical devices, API, Excipients- Implementation of Trade Compliance Policy, corporate standards and GMP/GDP- Monitoring of Excise goods, EMCS and ERP system - Ethanol, Mineral oils- Auditing and reporting activities and interface with Customs… Show more - Classification of products against trade requirements of government agencies - ŠUKL, MoH- Market access management activities in region of Central and Eastern Europe- License management of Merck & Sigma-Aldrich - IVD, Medical devices, API, Excipients- Implementation of Trade Compliance Policy, corporate standards and GMP/GDP- Monitoring of Excise goods, EMCS and ERP system - Ethanol, Mineral oils- Auditing and reporting activities and interface with Customs authorities- Country SME for Trade compliance surveillance - REACH, RoHS, Dual use, CWC, ODS, GMO- Authorized representative for Drug precursors cat. I and II- Certified representative for Toxic and Very toxic substances and mixtures- Policy direction, advice and guidance for export/import activities and HS classification Show less
Bratislava, Bratislava Region, Slovak Republic
- Leadership and Evaluation of team performance- Reporting activities to management and Business stakeholders- REACh management- Continuous improvement and Project management (LSS Sponsor, A3)- Quality management according to ISO 9001:2015- Implementation of corporate strategies
Slovensko
- People management (KPIs, Feedback sessions, Tasks distribution)- Coordination of Regulatory activities within corporate acquisitions- REACh compliance, Exposure scenarios- Continuous improvement (Lean Six Sigma)- Quality management according to ISO 9001:2008- E2E process optimization
Slovensko
- REACh investigation - ECHA, Only representatives, External suppliers- Evaluation of SDS, TDS and Specifications- Maintenance of Global inventory status of Raw materials- Master Data Management in SAP & Lotus notes - Maintenance of Chemical composition and GHS/CLP Labelling
Other employees you can reach at sobi.com. View company contacts for 1087 employees →
Ana Martin
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Greater Madrid Metropolitan Area, Spain
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SC
Sara Carlsson
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Greater Stockholm Metropolitan Area, Sweden
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AT
Ashley Teusink-Cross
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Cincinnati, Ohio, United States
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AL
Ana Luísa Amorim Afonso
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Portugal
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DI
Dad Is Gone
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Cambridge, England, United Kingdom
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IV
Isabelle Van Der Dussen De K.
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Antwerp Metropolitan Area, Belgium
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AJ
Axel Johansson
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Greater Stockholm Metropolitan Area, Sweden
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SP
Steven Pieri
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Pennington, New Jersey, United States
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KM
Kevin Manning
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Louisville Metropolitan Area, United States
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AL
Annelie Lundell
Colleague at Sobi - Swedish Orphan Biovitrum Ab (Publ)Stockholm County, Sweden
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- Focus on renewable resources and green chemistry, improving the economic balance of biofuels - Study of semi-batch and fixed-bed.
- Heterogeneous catalytic system study in vapor phase oxidation of amines by molecular oxygen
- General study of organic and inorganic chemistry and technology
Quick answers generated from the profile data available on this page.
Stanislav Vajicek, Phd works for Sobi - Swedish Orphan Biovitrum AB (publ).
Stanislav Vajicek, Phd is listed as Medical Governance Lead CEERJ+ at Sobi - Swedish Orphan Biovitrum AB (publ).
AeroLeads has found 1 work email signal at @henkel.com for Stanislav Vajicek, Phd at Sobi - Swedish Orphan Biovitrum AB (publ).
Stanislav Vajicek, Phd is based in Bratislava, Slovakia while working with Sobi - Swedish Orphan Biovitrum AB (publ).
Stanislav Vajicek, Phd has worked for Sobi - Swedish Orphan Biovitrum Ab (Publ), Baxter International Inc., Bloom Diagnostics, Merck Group, and Henkel.
Stanislav Vajicek, Phd's colleagues at Sobi - Swedish Orphan Biovitrum AB (publ) include Ana Martin, Sara Carlsson, Ashley Teusink-Cross, Ana Luísa Amorim Afonso, and Dad Is Gone.
You can use AeroLeads to view verified contact signals for Stanislav Vajicek, Phd at Sobi - Swedish Orphan Biovitrum AB (publ), including work email, phone, and LinkedIn data when available.
Stanislav Vajicek, Phd holds Doctor Of Philosophy - Phd, Organic Technology And Technology Of Fuels from Slovenská Technická Univerzita V Bratislave.
Stanislav Vajicek, Phd is listed with skills including Chemistry, Microsoft Office, Laboratory Skills, Gas Chromatography, Hplc, Analytical Chemistry, Originlab, and Sap.
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