LUCIE PELEKH
Richterswil
Summary
Dedicated and detail-oriented Regulatory Affairs and Pharmacovigilance Specialist with over 15 years of comprehensive experience in the pharmaceutical industry. Currently, I lead the Regulatory Affairs department at Medochemie Limited, Ukraine, a leading manufacturer of generic medicines with a global presence, the company operates in 122 countries and has 15 production sites. Driven by results and fueled by enthusiasm, I bring a proactive approach to achieving goals. Expert in regulatory documentation, quality management, and post-market surveillance for medicines, medical devices, and food supplements. With a rich and diverse background, I am committed to delivering excellence in all aspects of regulatory affairs and pharmacovigilance. My portfolio includes managing over 100 product combinations, demonstrating my extensive experience and expertise in the field.
Overview
21
21
years of professional experience
Work History
Regulatory Affairs Manager and Local Contact Person for Pharmacovigilance (LCPPV)
Representative Office “Medochemie Limited”
01.2016 - 06.2024
- Lead the Regulatory Affairs department at Medochemie Limited, Ukraine, a leading manufacturer of generic medicines with a global presence
- Managed the Ukrainian Regulatory Affairs team, overseeing objectives, reviews, and training
- Aligned regulatory strategies with commercial strategies, focusing on Pharmacovigilance (PV) and Quality Assurance (QA)
- Facilitated approval of submissions and handled documentation for Marketing Authorization
- Prepared Good Manufacturing Practices (GMP) documents for confirmation by local authorities
- Maintained company systems and databases in compliance with Standard Operating Procedures (SOPs)
- Built and nurtured relationships with agencies and corporate partners
- Prepared monthly and annual reports on regulatory affairs activities
- Updated summary of product characteristics (SmPC) and aligned labeling
- Prepared and confirmed packing materials as per local requirements
- Trained new team members and conducted annual pharmacovigilance training
- Assisted in preparing SOPs and monthly reports
- Reported Pharmacovigilance activities to the Pharmacovigilance & Medical Review Manager
- Managed over 70 product combinations, demonstrating extensive experience in regulatory affairs.
Regulatory Affairs Specialist
Representative Office “Medochemie Limited”
01.2007 - 01.2016
- Maintained Marketing Authorizations
- Prepared regulatory documentation for new registrations, renewals, and variation procedures
- Handled quality claims
- Prepared and adapted Certificates of Analysis (COAs) to local requirements.
- Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
Relationship and Regulatory Affairs Specialist
Representative Office “Neon Laboratories Limited”
01.2003 - 01.2007
- Prepared dossiers for registration, variations, and renewals, and handled registration processes
- Provided translational support ( module 1, Module 3 - registration dossier)
- Accompanied foreign delegations
- Coordinated administrative tasks and handled client queries
- Created KYC procedures and employee handbooks.
Education
Master’s Degree in General Pharmacy -
National Medical Academy of Postgraduate Education, Ministry of Health of Ukraine
01.2014
Bachelor’s Degree in Pharmacy -
Kyiv Medical University, Ukraine
01.2013
Bachelor’s Degree in English and Foreign Literature -
Lugansk Pedagogical University, Ukraine
01.2003
Skills
- Regulatory Submissions ( registration, renewals, variations)
- Quality Management
- GMP (15 production sites)
- Post Market Surveillance ( CIOMs, PSURs, RMPs, safety variations)
- Strong intercultural and communication and organizational skills
- Written Communication
- Medical Device Regulations
Languages
English (Fluent)
German (A2)
Ukrainian (Native)
Russian (Native)
Timeline
Regulatory Affairs Manager and Local Contact Person for Pharmacovigilance (LCPPV)
Representative Office “Medochemie Limited”
01.2016 - 06.2024
Regulatory Affairs Specialist
Representative Office “Medochemie Limited”
01.2007 - 01.2016
Relationship and Regulatory Affairs Specialist
Representative Office “Neon Laboratories Limited”
01.2003 - 01.2007
Master’s Degree in General Pharmacy -
National Medical Academy of Postgraduate Education, Ministry of Health of Ukraine
Bachelor’s Degree in Pharmacy -
Kyiv Medical University, Ukraine
Bachelor’s Degree in English and Foreign Literature -
Lugansk Pedagogical University, Ukraine
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