Stanislav Vajicek, Phd
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Stanislav Vajicek, Phd Email & Phone Number

Medical Governance Lead at Sobi at Sobi - Swedish Orphan Biovitrum AB (publ)
Location: Bratislava, Slovakia, Slovakia 8 work roles 4 schools
1 work email found @henkel.com LinkedIn matched
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Role
Medical Governance Lead at Sobi
Location
Bratislava, Slovakia, Slovakia
Company size

Who is Stanislav Vajicek, Phd? Overview

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Quick answer

Stanislav Vajicek, Phd is listed as Medical Governance Lead at Sobi at Sobi - Swedish Orphan Biovitrum AB (publ), a company with 1087 employees, based in Bratislava, Slovakia, 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 Medical Governance Lead CEERJ+ at Sobi - Swedish Orphan Biovitrum Ab (Publ) and Regulatory / Quality / Pharmacovigilance Manager CEE at Sobi - Swedish Orphan Biovitrum Ab (Publ). Stanislav Vajicek, Phd holds Doctor Of Philosophy - Phd, Organic Technology And Technology Of Fuels from Slovenská Technická Univerzita V Bratislave.

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Email format at Sobi - Swedish Orphan Biovitrum AB (publ)

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*@henkel.com
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Profile bio

About Stanislav Vajicek, Phd

✔️Regulatory Affairs ✔️Pharmacovigilance ✔️Quality Assurance ✔️Project management ✔️Continuous improvement

Listed skills include Chemistry, Microsoft Office, Laboratory Skills, Gas Chromatography, and 33 others.

Current workplace

Stanislav Vajicek, Phd's current company

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Sobi - Swedish Orphan Biovitrum AB (publ)
Sobi - Swedish Orphan Biovitrum Ab (Publ)
Medical Governance Lead at Sobi
solna, stockholm, sweden
Website
Employees
1087
AeroLeads page
8 roles

Stanislav Vajicek, Phd work experience

A career timeline built from the work history available for this profile.

Medical Governance Lead Ceerj+

Current

- 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.

Jan 2024 - Present

Regulatory / Quality / Pharmacovigilance Manager Cee

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.

Apr 2022 - Dec 2023

Regulatory Affairs Principal Specialist

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.

Jan 2020 - Mar 2022

Regulatory Affairs Manager

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.

Jul 2019 - Dec 2019

Senior Regulatory Affairs & Trade Compliance Specialist

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.

Nov 2017 - Jun 2019

Team Lead Regulatory Affairs

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

Feb 2017 - Oct 2017

Deputy Team Lead Regulatory

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

Mar 2016 - Jan 2017

Regulatory Specialist

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

Nov 2014 - Feb 2016
Team & coworkers

Colleagues at Sobi - Swedish Orphan Biovitrum AB (publ)

Other employees you can reach at sobi.com. View company contacts for 1087 employees →

4 education records

Stanislav Vajicek, Phd education

Doctor Of Philosophy - Phd, Organic Technology And Technology Of Fuels

- Focus on renewable resources and green chemistry, improving the economic balance of biofuels - Study of semi-batch and fixed-bed.

Master'S Degree, Chemical Process Technology, Faculty Of Chemical And Food Technology

- Heterogeneous catalytic system study in vapor phase oxidation of amines by molecular oxygen

FAQ

Frequently asked questions about Stanislav Vajicek, Phd

Quick answers generated from the profile data available on this page.

What company does Stanislav Vajicek, Phd work for?

Stanislav Vajicek, Phd works for Sobi - Swedish Orphan Biovitrum AB (publ).

What is Stanislav Vajicek, Phd's role at Sobi - Swedish Orphan Biovitrum AB (publ)?

Stanislav Vajicek, Phd is listed as Medical Governance Lead at Sobi at Sobi - Swedish Orphan Biovitrum AB (publ).

What is Stanislav Vajicek, Phd's email address?

AeroLeads has found 1 work email signal at @henkel.com for Stanislav Vajicek, Phd at Sobi - Swedish Orphan Biovitrum AB (publ).

Where is Stanislav Vajicek, Phd based?

Stanislav Vajicek, Phd is based in Bratislava, Slovakia, Slovakia while working with Sobi - Swedish Orphan Biovitrum AB (publ).

What companies has Stanislav Vajicek, Phd worked for?

Stanislav Vajicek, Phd has worked for Sobi - Swedish Orphan Biovitrum Ab (Publ), Baxter International Inc., Bloom Diagnostics, Merck Group, and Henkel.

Who are Stanislav Vajicek, Phd's colleagues at Sobi - Swedish Orphan Biovitrum AB (publ)?

Stanislav Vajicek, Phd's colleagues at Sobi - Swedish Orphan Biovitrum AB (publ) include Malin Öhman, Cecilia Greder, Kevin Manning, Christophe Hublet, and Shane Melton, M.S..

How can I contact Stanislav Vajicek, Phd?

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.

What schools did Stanislav Vajicek, Phd attend?

Stanislav Vajicek, Phd holds Doctor Of Philosophy - Phd, Organic Technology And Technology Of Fuels from Slovenská Technická Univerzita V Bratislave.

What skills is Stanislav Vajicek, Phd known for?

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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