Mariia Melnyk
Berlin
Summary
Highly qualified Regulatory Affairs Manager developing and implementing regulatory strategies that achieve compliance with government regulations. Adept at fostering strong relationships with regulatory agencies and stakeholders to achieve business objectives while upholding the highest standards of quality and ethics. Excellent analytical and problem-solving abilities combined with detail-oriented approach to streamline processes and enhance regulatory operations.
Overview
8
8
years of professional experience
Work History
Regulatory Affairs Manager
Zentiva Pharma GmbH
01.2023 - Current
- Co-developed and executed regulatory strategy (monthly variation submission plan) focused on labeling and CMC variations aligned with national and global regulatory requirement and enterprise objectives.
- Collaborated with cross-functional teams (Quality, Operations etc.) to ensure timely implementation of labeling and CMC variation submissions and contributed insights and recommendations to improve and adapt strategic steps based on company's regulatory stage, fostering alignment across teams and enhancing organizational effectiveness.
- Reviewed documentation for new Marketing Authorizations, ensuring compliance with regulatory standards and organized variation submission dossiers utilizing Electronic Common Technical Document (eCTD) format for registered products.
- Ensured accurate and up-to-date records within RIM system to facilitate efficient regulatory processes and compliance.
- Engaged in frequent and proactive communication with health authorities to advance regulatory strategies and achieve organizational goals.
- Developed and executed proactive measures to identify and address regulatory risks, ensuring adherence to regulations and minimizing compliance challenges.
- Managed fees and applications, tracked product process and progress, handling all responses to regulatory inquiries.
- Spearheaded training initiatives for staff and new colleagues on regulatory affairs topics, promoting culture of continuous learning.
Junior Regulatory Affairs Manager
Aristo Pharma GmbH
08.2022 - 12.2022
- Orchestrated variation submission processes, including formation of eCTD sequences, preparation of official correspondence to health authorities, and adaptation of product information texts for labeling variations.
- Devised and deployed techniques (submitting variations as cost efficient as possible e.g. grouping, structured coordination with local stakeholders) for obtaining earliest possible approval for each product.
- Support Business development, New launches and Tender by keeping them updated on risks and chances concerning ongoing procedures.
Community Pharmacist
Pharmacy "Am Kurfürstendamm"
10.2021 - 06.2022
- Health Monitoring and Medication Management creation: Ensuring proper storage, handling, and labeling of medications.
- Ensured pharmacy adheres to legal and regulatory standards.
- Assisted patients with over-the-counter medication recommendations and responded to questions concerning drug interactions.
- Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.
Community Pharmacy Internships
Pharmacy "Am Kurfürstendamm"
11.2020 - 04.2021
- Dispensed prescription medications accurately and efficiently to patients following all legal requirements and ethical standards.
- Provided patient counseling on medication usage, side effects, and potential interactions to ensure safe and effective treatment outcomes.
- Conducted medication therapy management services, including medication reviews and adherence counseling, to optimize patient health outcomes.
Pharmacist Intern, Regional Sites Coordination
Bayer AG
05.2020 - 10.2020
- Assisted in preparing Quality Management Review compliant with GMP standards encompassing seven globally dispersed production sites across Europe, Asia, and Latin America.
- Provided support on GMP-related concerns, conducted root cause analyses for deviations, and collaborated with quality teams at manufacturing sites in defining corrective and preventive measures.
- Provided support in training of new employees in Site Quality Management Review Process
- Developed training videos for independent verification of Quality Management data reliability at various locations in world.
Student Worker
Pharmacy "Sundgau"
05.2016 - 06.2019
- Managed manufacturing process of various drugs including creams, tablets, and suppositories.
- Conducted inventory management activities to ensure adequate stock levels of pharmaceutical products.
- Assisted pharmacists with medication procurement, storage, and distribution processes.
Education
Doctor of Pharmacy - Pharmacy
Freie University Berlin
Berlin, Germany08-2021
Skills
- Regulatory Strategy
- CMC change control management
- Health Authority Negotiations
- Risk Management
- International Regulations
- Project overview
- Virtify eCTD
- Product Lifecycle Management
- Regulatory Submissions
- Regulatory Intelligence
- Staff Training
- Regulatory Agency Applications
Software
- Electronic document management system (eDMS)
- CMC change control management
- Electronic Common Technical Document (eCTD)
- MS Office
Timeline
Regulatory Affairs Manager
Zentiva Pharma GmbH
01.2023 - Current
Junior Regulatory Affairs Manager
Aristo Pharma GmbH
08.2022 - 12.2022
Community Pharmacist
Pharmacy "Am Kurfürstendamm"
10.2021 - 06.2022
Community Pharmacy Internships
Pharmacy "Am Kurfürstendamm"
11.2020 - 04.2021
Pharmacist Intern, Regional Sites Coordination
Bayer AG
05.2020 - 10.2020
Student Worker
Pharmacy "Sundgau"
05.2016 - 06.2019
Doctor of Pharmacy - Pharmacy
Freie University Berlin
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