Володимир

VLADIMIR ZHURAVEL
Regulatory Affairs | Pharmacovigilance | Сosmetic products

Ukraine/ Kyiv | [відкрити контакти](див. вище в блоці «контактна інформація») | [відкрити контакти](див. вище в блоці «контактна інформація») | [відкрити контакти](див. вище в блоці «контактна інформація»)
zhuravel

PROFESSIONAL SUMMARY

Specialist with 10+ years of experience in pharmaceuticals, consumer healthcare, and public
health. Proven track record in regulatory Affairs, pharmacovigilance, cosmetic documentation
(including PIF), and regulatory compliance across Ukraine and CEE. Strong experience in
handling customer and internal requests related to product composition, safety, and
sustainability topics. Skilled in working with global teams and health authorities.

CORE SKILLS

Regulatory Affairs | Lifecycle Management | Pharmacovigilance | Cosmetic documentation
(PIF) | Sustainability Requests | Health Authority Communication | Compliance | Data Analysis |
Cross-functional Collaboration

PROFESSIONAL EXPERIENCE

Regulatory Affairs Specialist – Kenvue Ukraine LLC (earlier - Johnson & Johnson
Ukraine LLC)

Sep 2021 – Present

- Manage end-to-end regulatory processes for medicinal and consumer healthcare products
- Prepare and submit registration dossiers, SmPC, CCDS updates
- Maintain lifecycle activities: variations, renewals, PSUR submissions
- Ensure compliance for cosmetic products: PIF preparation, SKU notification, labeling review
- Act as key contact with Health Authorities and resolve regulatory queries
- Support regional (EMEA) teams with local regulatory intelligence
- Handle internal and external requests related to product information including ingredients
and compliance
- Participation in payment of the invoices regarding registration processes and interaction
with contractors
- Formation and submission of dossiers for recognition of GMP certificates

Pharmacovigilance Specialist – Darnitsa (Feb 2016 – Sep 2021)

- Prepared and submitted PSURs to regulatory authorities
- Developed safety documentation (SmPC, PIL, RMP, Annex 13, ACO, PV system)
- Analyzed adverse reactions and safety signals
- Reviewed literature and regulatory data sources
- Responded to Health Authority comments
- Participation in payment of the invoices regarding registration processes and interaction
with contractors
Head of Sanitary-Quarantine Unit MA "Kyiv" (Zhuliany) – Ministry of Health of
Ukraine (Jun 2014 – Present)
- Led public health and epidemiological operations at international airport
- Analyzed global disease trends (WHO) and prepared risk assessments
- Coordinated emergency response and preventive measures
- Managed stakeholder communication and reporting

Earlier Roles in Epidemiology & Public Health (2011 – 2014)

- Epidemiological investigations and surveillance
- Regulatory inspections and compliance activities
- Data analysis and reporting on infectious diseases
- organization work of the department;
- organization and control of anti-epidemic measures;

Doctor-coordinator GARANT-ASSISTANCE - NJSIC "ORANTA" (Feb 2012 -Oct 2012)
- organization of routine and urgent medical care for the clients of the company (doctor's
consultation, examination and medicines)

EDUCATION

2022-2023 Master of medical sciences, postgraduate diploma Management in the
field of health care", O.O. Bogomolets National Medical University, Kyiv, Ukraine

2012-2013 Physician, postgraduate internship in epidemiology, O.O. Bogomolets
National Medical University, Kyiv, Ukraine

2005-2011 Medical student medical case, O.O. Bogomolets National Medical
University, Kyiv, Ukraine

CERTIFICATIONS

The new law on medicinal products: preliminary analysis and action plan for
registrants, 2022
Criteria for evaluating the effectiveness of the applicant's pharmacological examination
systems, 2020
Signals in the system of pharmacological examination of the applicant: role, management
process, development scenarios, 2020
Audit of systemic pharmacovigilance of the applicant - preparation, carrying out, results,
2019
"Risk Management in Pharmacovigilance", 2017
"Approaches and Methods for Assessing the Benefit/Risk Ratio", 2017
"Re-registering medicines in the new format: how to prevent mistakes and pass an
examination without delay?", 2016
"Principles and approaches to determining the benefit, risk of drugs and the benefit-
risk ratio", 2016
"Pharmacovigilance for beginners: from" A "to" I "in one session!", 2016
Pharmacovigilance Audit, 2016
"Effective communication tools", 2012
LANGUAGES

Ukrainian – Native | Russian – Fluent | English – Upper-intermediate