Viktar Brundukou
Warsaw
Summary
Proficient in current Pharmaceutical regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
10
10
years of professional experience
Work History
Regulatory Affairs Executive, CIS/Asia/NE Cluster
GSK Services Sp Z. O. O.
04.2023 - Current
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Streamlined submission processes for improved efficiency and timely approvals from regulatory agencies.
- Maintained comprehensive knowledge of regional regulations, aiding in the adaptation of strategies across international markets.
- Championed cross-functional collaboration by establishing regular meetings with relevant departments, ensuring seamless project execution.
- Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
- Provided expert guidance on global regulations, leading to successful market entry of new products.
- · Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Content Delivery and 3rd Party Service Provider to support regulatory submissions to local regulatory agencies.
- Consulted with regulatory representatives to manage filings, applications, and reports.
- Provided responses to regulatory agencies regarding product information or issues.
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- · Effective communication, collaboration, planning and oversight of Regulatory Third-Party service providers to achieve Regulatory objectives and meet compliance standards.
Regulatory Affairs Manager
Takeda Osteuropa Holding GmbH (Austria)
04.2021 - 03.2024
- Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Championed cross-functional collaboration by establishing regular meetings with relevant departments, ensuring seamless project execution.
- Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Maintained comprehensive knowledge of local and regional regulations, aiding in the adaptation of strategies across international markets.
- Prepared and maintained document inventory for registration dossier preparation for new drug applications, renewals and variations in accordance with national and Eurasian legislation.
- Streamlined submission processes for improved efficiency and timely approvals from regulatory agencies.
- Successfully navigated complex regulations for various types of drug products during their lifecycle stages.
- Evaluated emerging legislation and its potential impact on current products or future developments.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Provided responses to regulatory agencies regarding product information or issues.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Managed all regulatory needs for products such as oncology and rare diseases along with general medicines products.
- Ensured organization and supervision of GMP inspections.
Regulatory Affairs Specialist (Contingent Worker)
Takeda Osteuropa Holding GmbH (Austria)
05.2018 - 03.2021
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
- Participated in negotiations with regulators during inspections or audits, advocating on behalf of the company''s best interests while respecting agency expectations.
- Prepared and submitted regulatory file applications and supporting documentation.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Maintained and archived regulatory paperwork.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Evaluated new business opportunities from a regulatory perspective, providing valuable insight into potential challenges or benefits.
- Prepared and maintained document inventory for core dossier preparation.
- Stayed updated on changing regulations by attending industry conferences, maintaining professional expertise in the field.
- Contributed to successful product launches by coordinating with various departments to ensure all necessary approvals were obtained beforehand.
- Established strong relationships with global regulatory counterparts, facilitating efficient information exchange and collaboration.
- Advised executive management on the strategic direction of regulatory activities, incorporating both short-term and long-term goals for the company.
- Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Delivered high-quality results under pressure, consistently meeting demanding deadlines without compromising on standards or attention to detail.
Regulatory Affairs Officer
UAB Biomapas
05.2017 - 03.2021
- Prepared and maintained document inventory for core dossier preparation.
- Represented company in [Type] industry during communications with global regulatory agencies.
- Provided valuable input on product development initiatives, offering expert guidance on potential regulatory challenges or concerns throughout the process.
- Facilitated smooth communication between departments by serving as the primary liaison between regulatory affairs and other functional areas within the organization.
- Led efforts to obtain necessary certifications for products, allowing for increased market access and revenue growth.
- Enhanced company compliance with FDA regulations through thorough review and editing of product labeling and promotional materials.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Provided responses to regulatory agencies regarding product information or issues.
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Advice/support for the preparation/ assistance in submission of regulatory applications, including but not limited to new applications, variations and renewals, in Belarus, and subsequent correspondence with the Regulatory Authority as required to obtain approval;
- Continuous update on the national regulatory requirements in in Belarus;
- English translations of local regulations and/or Regulatory Authority communication in Belarus (letters, emails, fax), when available only in local languages;
- Support with medical device notification;
- Support with promotional material review and submission to National Competent Authority;
Regulatory Affairs Specialist
Reb-Pharma, Trade Unitary Enterprise
10.2014 - 05.2017
- Participated in negotiations with regulators during inspections or audits, advocating on behalf of the company''s best interests while respecting agency expectations.
- Analyzed competitor data, staying informed about industry developments that could impact current or future products.
- Maintained and archived regulatory paperwork.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Evaluated new business opportunities from a regulatory perspective, providing valuable insight into potential challenges or benefits.
- Prepared and maintained document inventory for core dossier preparation.
- Contributed to successful product launches by coordinating with various departments to ensure all necessary approvals were obtained beforehand.
- Supported product development by offering guidance on applicable regulations throughout the process, ensuring adherence at every stage.
- Preparation and maintenance of technical files as necessary to obtain and sustain product approval
- ·Communication with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
Education
Master of Science - Food Innovation And Product Design
AgroParisTech
Paris, France09.2012
Bachelor of Science - Chemistry. Pharmaceutical Activities
Belarus State University
Minsk, Belarus06.2012
Skills
- Submission preparation
- License Maintenance
- Regulatory Agency Liaison
- Good Manufacturing Practices
- Electronic Common Technical Document
- Data Gathering
- Regulatory research
- Document Management
- Regulatory Submissions
- Regulatory Strategy
- Product Labeling
- Pharmaceutical Regulations
- Regulatory Intelligence
- Change Management
- Eurasian Union Regulations
- Project Management
- Inspections
- Database Maintenance
Accomplishments
- Program Management: - [Describe accomplishment 1].[Describe accomplishment 2].Public Relations: - [Describe accomplishment 1].[Describe accomplishment 2].
- Documented and resolved [Issue] which led to [Results].
Languages
Russian
Native language
English
Advanced
C1
French
Upper intermediate
B2
Polish
Intermediate
B1
Timeline
Regulatory Affairs Executive, CIS/Asia/NE Cluster
GSK Services Sp Z. O. O.
04.2023 - Current
Regulatory Affairs Manager
Takeda Osteuropa Holding GmbH (Austria)
04.2021 - 03.2024
Regulatory Affairs Specialist (Contingent Worker)
Takeda Osteuropa Holding GmbH (Austria)
05.2018 - 03.2021
Regulatory Affairs Officer
UAB Biomapas
05.2017 - 03.2021
Regulatory Affairs Specialist
Reb-Pharma, Trade Unitary Enterprise
10.2014 - 05.2017
Master of Science - Food Innovation And Product Design
AgroParisTech
Bachelor of Science - Chemistry. Pharmaceutical Activities
Belarus State University
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