Marína Rudašová
Praha 8 Březiněves
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Specialist
Johnson & Johnson
07.2021 - Current
- Enhanced regulatory compliance by developing and implementing robust policies and procedures.
- Streamlined internal processes for timely submission of regulatory documentation to authorities.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
- Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
- Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
RA country coordinator
Regulatory Projects and Development, Zentiva group, a.s.
07.2016 - 06.2021
- Close cooperation with European affiliates/Branch offices RA teams and management of implemented processes in relevant countries - ensuring all submissions on time related to new registrations, portfolio maintenance and related regulatory activities, processes, regulatory requirements, and people development
- Assuring proper information sharing between Central RA/RSO and Affiliates/Branch offices and external partner responsible for export countries; Distribution of the legislation and obligatory trainings to the European countries, or to the internal departments
- Budget preparation and adherence - regular monitoring of the spending, corrective actions where applicable
- Ensuring Renewal plan preparation, updating and monitoring of the plan and communication to relevant department
- Pruning process management; Consolidation of Withdrawal plan; Regularly updating of plans; Coordination of evaluation of withdrawal requests; SOP preparation; Monitoring of Sunset clause impacted products through Affiliates
- Ensuring registration fees payments, monitoring of updates in registration fees in relevant countries
- Change control management, initiation of the change request in paper version and electronically, coordination of proper execution of CR
- Coordination of Article 23 - Management of reporting events to regulatory Authorities for events validation, SOP preparation and updating
- Supervising of contractor activities
RA coordinator
Regulatory Projects and Development, Zentiva group, a.s.
07.2016 - 06.2018
- Daily communication with European affiliates
- Consolidation of Monthly registration plan
- Teleconference organization, scheduling of TC´s, agenda preparation and communication, meeting minutes consolidation
- Renewal plan consolidation
- Distribution of the legislation
- Updating RA fees, European RA contacts and product responsibility lists
- Distribution of obligatory trainings throw the Affiliates
- Change control initiation
- Monthly consolidation of Gx events for reporting to Regulatory Authorities
PhD Student
Department of analytical chemistry, Faculty of Natural Sciences, Comenius University in Bratislava
09.2012 - 07.2016
- Analysis of pharmaceutical preparations by microchip electrophoresis
- Evaluation and data processing, design of new methods and procedures
- Presentation of measured results at domestic and international conferences
- Teaching practical exercises of analytical chemistry
- Writing publications, abstracts
- Elaboration of various projects and grants
Education
PhD (Doctor philosophiæ), Doctorate -
Comenius University, Faculty of Natural Sciences
Mgr. (Master of Analytical chemistry), Master of Science -
Department of analytical chemistry, Faculty of Natural Sciences, Comenius University in Bratislava
Bc. (Bachelor), Bachelor of Science -
Department of organic chemistry, Faculty of Natural Sciences, Comenius University in Bratislava
Skills
- Impact Assessment
- Data Verification
- Information Verification
- Technical Guidance
- Global Regulatory Compliance
- Product Information
- Project Management
- Pharmaceutical Industry Knowledge
- Medical Device Regulations
- Regulatory Training
- Time Management
- Data Analysis
- Database Maintenance
Languages
Slovak
Native or Bilingual
Czech
Native or Bilingual
English
Full Professional
Personal Information
- Date of Birth: 01/04/88
- Gender: Female
- Nationality: Slovak
- Driving License: Class B
Timeline
Regulatory Affairs Specialist
Johnson & Johnson
07.2021 - Current
RA country coordinator
Regulatory Projects and Development, Zentiva group, a.s.
07.2016 - 06.2021
RA coordinator
Regulatory Projects and Development, Zentiva group, a.s.
07.2016 - 06.2018
PhD Student
Department of analytical chemistry, Faculty of Natural Sciences, Comenius University in Bratislava
09.2012 - 07.2016
PhD (Doctor philosophiæ), Doctorate -
Comenius University, Faculty of Natural Sciences
Mgr. (Master of Analytical chemistry), Master of Science -
Department of analytical chemistry, Faculty of Natural Sciences, Comenius University in Bratislava
Bc. (Bachelor), Bachelor of Science -
Department of organic chemistry, Faculty of Natural Sciences, Comenius University in Bratislava
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