Vyacheslav

CURRICULUM VITAE

VYACHESLAV TIMOSHENKO
Phone: [відкрити контакти](див. вище в блоці «контактна інформація»);
E-mail: [відкрити контакти](див. вище в блоці «контактна інформація»);
Linkedin: [відкрити контакти](див. вище в блоці «контактна інформація»)
Location: Kyiv, Ukraine;

Trainings:
09.04.2025 - UA Right webinar "Changes to registration dossier materials: preparing together for the eCTD format".

CAREER SUMMARY:`
May 2018 – present time “Johnson and Johnson Ukraine LLC”
Regulatory affairs specialist

Job responsibilities:

Assessment of registration materials for compliance with the regulatory requirements of Ukrainian legislation.
Preparation and submission of registration materials for registration, renewal and variations to registration materials for medicinal products in accordance with Ukrainian legislation.
Participation in the development of plans for the registration of new medicinal products, provision of substantiated regulatory decisions for any proposed regulatory strategy, assessment of potential regulatory risks.
Communication with the regional team and manufacturers to obtain additional documents/information required for registration processes;
Ensuring effective interaction with health regulatory authorities.
Preparation of PIL draft for registration, renewal, variations to PIL according to updated safety data, clinical studies, updated CCDS, SmPC, PRAC recommendations, etc.
Preparation of updated MQC, labeling text (if necessary).
Requesting and submitting of PSURs, according to the submission schedule.
Preparation and submission of dossiers for GMP recognition (including document request, compliance check, development of local documents, preparation of documents for submission, communication with government agencies).
Requesting, reviewing and approving of packaging artworks for medicinal products.
Reviewing and approval of promotional materials for medicinal products.
Cooperation with the local team on the timing of receipt of approved registration documents and artworks to ensure uninterrupted supply of products and launch of new products.
Preparation and support of internal and external audits and inspections, including quality assurance, pharmacovigilance and changes in regulatory legislation.
Support of the quality team on batch release and issues arising (if necessary).
Support of regional and local databases.
Regular meetings with regional and local colleagues, correspondence, negotiations.
Declaration of prices for medicinal products in the National Price Catalog.
Verification and approval of stickers for cosmetic products.
Participation in preparation for notification of cosmetic products.
Participation in budget planning for registration procedures, payment of the invoices and financial monitoring of current expenses;
Monitoring changes in regulatory legislation in Ukraine; timely informing regional colleagues about local regulatory requirements/legislation and changes in requirements.

April 2015 – April 2018 Pharmaceutical company “Darnitsa”
Lead regulatory affairs specialist
Job responsibilities:
Main responsibilities:
Realization of the registration process for companies products in line with current Ukrainian and Vietnamian legislation: preparing, submitting, updating and following up, in time registration dossiers for new marketing authorisation, renewals and all types of variations for marketing authorization. Monitoring of the registration process, responding to the comments of Regulatory Authorities experts, communication with employees of the State Expert Center. Cooperation with any further information requests from Regulatory Authorities. Following up all steps for authorization/approval of submissions. Approving the drafts (received from MoH) of registration certificates, PILs, ANDs and other regulatory documents on their correctness and completeness.

EDUCATION:
2024 - Master of Science in Healthcare management, Bogomolets National Medical University, Kyiv;
2008 - PhD on “Plant physiology” - Institute of plant physiology and genetics, National Academy of Sciences of Ukraine, Kyiv;
2003 - Master of Science in plant physiology and biochemistry, Kharkov National University, Kharkiv;
2002 - Bachelor of Science in plant physiology and biochemistry, Kharkov National University, Kharkiv.

BEHAVIOURAL COMPETENCIES AND SKILLS:
Co-operation and teamwork;
Ability to proactively face and solve potential or actual problems;
Good internal and external communicator;
Ability to deal with complexity;
Results oriented;
Sociability, systematic, attentiveness, punctuality, the ability to work under pressure and to strict deadlines;
-Project Conceptualizing and Leading;
Knowledge of medicines registration legislation Ukraine and Europe;
Ability to build productive partnership with different external and internal stakeholders;
Сross functional interaction.