Зоя

Zoia Experience
Godetska Senior Regulatory Affairs Specialist CIS
Senior Regulatory MSD Ukraine LLC
Affairs Specialist CIS Kyiv, Ukraine
Apr2013 – Apr2026
Key responsibili es:
- Training & Compliance Officer (T&C Officer) for CIS
market (Armenia, Azerbaijan, Belarus, Georgia, Moldova,
Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan,
Uzbekistan and Mongolia).
- Subject Ma er Expert in the different global data bases
(Health Regulatory Management, Regulatory
Requirements databases, Archiving Systems).
For assigned products, ensures mely prepara on,
Contact
submission, and appropriate follow-up of new Marke ng
Authoriza on Applica ons to the local authori es.
Ensures maintenance of assigned, authorized products
through mely submission of varia ons, renewal
applica ons, and supplemental marke ng
authoriza ons.
Collects relevant publicly available regulatory
informa on appropriately informed and keeps relevant
persons.
Maintains a posi ve rela onship with internal and
external regulatory contacts. GRACS on sub-regional,
regional, and global level, MMD, PV and Global Labeling
are the main contact points within the company. External
Educa on
contacts are regulatory authori es, as well as other key
1993 Kyiv State Linguis cs
University Master Degree players in the regulatory environment.

New MA applica ons for assigned products:
Performs mely and correct submission and approval of
Skills assigned new Marke ng Authoriza on applica ons in
Compliance & Audit Readiness close coopera on with relevant persons in the managing,
Regulatory Documenta on Control
medical, finance, customer service, marke ng and
Regulatory database compliance
Cross-Func onal Regulatory external affairs departments, GRACS on sub-regional,
Communica on regional and globallevel, as well as with local regulatory
authori es as appropriate, depending on procedure type.

*I hereby consent to the processing of my personal data for the purpose of conduc ng the recruitment process for the posi on I am applying for. I also consent to the processing of my
personal data for the purposes of future recruitment processes.

Tracks process and manages answers to objec ons from
the Agency on products registra on and major new
indica ons, involving nego a ons to achieve best
condi ons.
Maintenance of licenses for assigned products. Ensures
that marke ng authoriza ons are maintained in
compliance with related regulatory areas, through
performing the necessary ac vi es, including varia ons
and renewals, with a high standard and within the agreed
meframes and communicates approvals to stakeholders
through the correct processes.
For major indica ons, implements local ac on plans as
above men oned for new MA applica ons.

Compliance:
Ensuring company regulatory database is mely updated
with core regulatory informa on and is supported by
adequate documenta on, collabora on with func onal
area stakeholders, business process leads, and business
system produc on support organiza on to develop
business process; Contribu ng to development and
maintain of relevant Standard Opera ng Procedures to
secure compliance with current regula ons.
Collabora ng with Management Team to provide the
latest updates on compliance requirements.
Overseeing mely comple on of training assigned by all
RA employees.
Maintaining training log updated, preparing the reports.
Maintain high level of compliance and audit readiness via
ensuring global system, business partnership informa on
pla orms, Business Development Lifecycle Management
system, and local tracking regulatory so ware systems
are duly updated with core regulatory informa on.
For new regula ons, iden fies and tracks changes/trends
that might impact MSD business.

*I hereby consent to the processing of my personal data for the purpose of conduc ng the recruitment process for the posi on I am applying for. I also consent to the processing of my
personal data for the purposes of future recruitment processes.

Zoia Experience
Godetska
Regulatory Affairs Specialist CIS
Pharma Personal Service LLC (working under contract
for MSD Ukraine LLC)
Kyiv, Ukraine Key
Sep2011 - Apr2013
Key responsibili es:
For assigned products (Emend IV, Emend capsules, H-B-
Vax, Pneumovax, RotaTeq, Tredap ve, Brineviss), ensures
mely prepara on, submission, and appropriate follow-
up of new MAAs to the local HA of Armenia, Azerbaijan,
Belarus, Georgia, Moldova, Mongolia, Kazakhstan,
Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan.
Ensures maintenance of assigned, authorized products
through mely submission of varia ons, renewal
applica ons, and supplemental marke ng
authoriza ons.
Performs mely and correct submission and approval of
assigned new Marke ng Authoriza on applica ons in
close coopera on with relevant persons in the managing,
medical, finance, customer service, marke ng and
external affairs departments, GRACS on sub-regional,
regional and global level, as well as with local regulatory
authori es as appropriate, depending on procedure type.
Ensures that marke ng authoriza ons are maintained in
compliance with related regulatory areas, through
performing the necessary ac vi es, including varia ons
and renewals, with a high standard and within the agreed
meframes and communicates approvals to stakeholders
through the correct processes.
For assigned products, ensures mely prepara on and
maintenance of local SPC, PPI, instruc ons for medical
use, packaging material and other applicable regulatory
documents according to MSD and local standards and
Artwork Management procedures.
Implement Prescribing Informa on within the correct
meframes for compliance.

*I hereby consent to the processing of my personal data for the purpose of conduc ng the recruitment process for the posi on I am applying for. I also consent to the processing of my
personal data for the purposes of future recruitment processes.

Zoia Experience
Godetska
Regulatory Affairs Specialist in CIS countries
Herbs Trading GmbH Austria in Ukraine
Kyiv, Ukraine
Apr2008 - Aug2011
Key responsibili es:
Prepara on of registra on dossiers for new registra on,
renewals and all types of changes.
Adap ng of analy cal documents, technological
documents, leaflets.
Work with the MOH of the CIS countries (Armenia,
Azerbaijan, Belarus, Georgia, Kazakhstan and
Uzbekistan).
Close correspondence with Head Officeof the Herbs
Training, answers for requirements, preparing of reports.
Registra on of food supplement in Armenia, Azerbaijan,
Belarus, Georgia, Kazakhstan and Uzbekistan.
Work with Laboratories of quality control in Belarus,
Georgia, Kazakhstan and Uzbekistan.
Artwork prepara on for the medicinal products, medical
devicesand the food supplements with the different
agencies and the manufacturing sites.

Assistant of the Regulatory Affairs Manager in
Ukraine
Herbs Trading GmbH Austria in Ukraine Kyiv,
Ukraine, Kyiv
Feb2008 - Apr2008
Key responsibili es:
Prepara on of the different transla on of the requests to
Head Office and to MoH of Ukraine within the new
submissions, renewals and other varia ons.
Collabora on with the logis cs department.
Prepara on the different regulatory reports for Head
Office.

*I hereby consent to the processing of my personal data for the purpose of conduc ng the recruitment process for the posi on I am applying for. I also consent to the processing of my
personal data for the purposes of future recruitment processes.

Artwork prepara on as a second reviewer for the
regulatory ac vi es.

Workshops
Psychological trainings “Emo onal Intelligence” “Mental
Health Awareness_Kyiv, Ukraine (Aug 2025, Nov 2025)
Psychological training “Self-Care Strategies During
Prolonged Stress”_Kyiv, Ukraine (May 2024)
Psychological training “Personal success”_Kyiv, Ukraine
(2022)
Effec veness team, Self-development, Conflict-free
Workshops_Kyiv, Ukraine (2020)
Effec ve interac ons and agreements_Kyiv, Ukraine
(2019)
Influence and asser ve behavior_Kyiv, Ukraine (2019)
Business nego a ons_Budapest, Hungary (2018)
Innova on training_Tbilisi, Georgia (2017)
Emo onal Intelligence: personality skills_Lviv, Ukraine
(2017)
Insights training_Kyiv, Ukraine (2016)
Effec ve project management_Napareuli, Georgia (2015)
EUCRAF Good Regulatory Affairs prac ce_Freiburg,
Germany (2012)

*I hereby consent to the processing of my personal data for the purpose of conduc ng the recruitment process for the posi on I am applying for. I also consent to the processing of my
personal data for the purposes of future recruitment processes.