Richard Schulz
Třebotov
Summary
Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.
Overview
27
27
years of professional experience
Work History
Manager of Global Regulatory Affairs
ICON, PRA Health Sciences
04.2020 - 11.2024
- Provide line management to direct reports, including professional development, performance appraisals and employee counseling/mentoring
- Management and coordination of resources and reviews workloads of direct reports
- Perform role of Local Reviewer in the QC process as appropriate
- Providing consultancy to the client on any country specific issues, if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM)
- Attending internal and external project team meetings as determined by the scope of work (SOW)
- SUL, CTM or PM
- If applicable for the Country, perform the NDSLS role and submit expedited safety reports and
- DSURs to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement
- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e
- Regulatory agency (RA), central independent ethics committee (IEC) and any other central authorities for the assigned country/countries
- Management of central/country level submissions associated with ensuring investigational product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the lead regulatory affairs associate (LRAA) is responsible for
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable
- Management of the central/country level informed consent and any other documentation given to patients i.e
- Diaries, questionnaires through to submission and approval by country level RA and
- Central IEC as appropriate
- Tracking and reporting of central submission/approval progress in clinical trials management system (CTMS), eTMF and other applicable PRA systems
- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e
- Regulatory agency (RA), central independent ethics committee (IEC) and any other central authorities for the assigned country
- Country Consultancy activities connected with quality of submitted documents
- Management of country level submissions associated with ensuring investigational product (IP) and any other clinical trial supplies can be imported and where applicalble, exported into/from the country the LRAA is responsible for
- Performing also activities of Local Label Expert by ensuring that IP labels are in adherence to country requirements and submitted where applicable
- Management of the country level informed consent and any other documentation given to patients, through to submission and approval by country level RA and Central IEC as appropriate
- Tracking and reporting of central submission/approval progress in clinical trials management system (CTMS, PhlexCTMS) over 25 years of experience in pharma industry, since 1996 different roles in CT industry
- Experience from conduct of CT, regulatory submissions planning, line management, project management, regulatory, project delivery, communication with sponsoring companies
- Take on responsibility for subject matter expert (SME) as designated by GRA management
- May perform the role of local reviewer in the QC process as appropriate
- Provide mentoring and training for less experienced team members
- Support more junior team members with more complex submissions requirements or more complex logistics tasks, as appropriate
- Support the development of new processes
- May be delegated ownership for areas of the country knowledge repository and be responsible for liaising with other operational departments to ensure the database contains accurate country intelligence
- Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the country knowledge repository and the country fact sheets are up to date; communicate new information or changes to the regulatory intelligence consultant team
- May work with GRA team members to provide regulatory or logistics, as appropriate, consulting services
- Richard Schulz, MUDr
- Curriculum Vitae ofPage 2 10 eTMF and other applicable PRA systems
- Perform role of local reviewer in the QC process as appropriate
- Providing consultancy to the client on any country specific issues, if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM)
- Attending internal and external project team meetings as determined by the scope of work (SOW)
- SUL, CTM, or PM
- If applicable for the Country perform the NDSLS role and submit expedited safety reports and DSURs to RA and Central IEC in accordance with relevant legislation and the project specific contractual agreement
- Accomplishments I and team of my direct reports, we constantly are achieving full compliance with PRA system and we are achieving constantly excellent result in keeping timelines of any kind of submissions to central IEC and RA.
Regulatory Affairs Specialist
PRA Health Sciences
12.2015 - 03.2020
- Any other duties deemed necessary to secure the success of PRA’s business
- Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that information are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems
- Support RAA 1 and 2 with more complex submissions requirements
- Management of the central/country level Informed Consent and any other documentation given to patients i.e
- Diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate
- Provide mentoring and training for the RAA 1 and RAA 2 position
- Provide line management to direct reports, including professional development, performance appraisals and employee counseling / mentoring
- May serve as Country Consultant and be involved in Business Development activities if required for their country(s)
- Managing and coordinating resource and reviews workloads of direct reports
- Country Knowledge Repository
- Providing consultancy to the client on any country specifics issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM)
- Supporting the Senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date
- Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM
- If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable
- May work with GRA team members to provide Regulatory consulting services
- Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for
- Perform role of Local Reviewer in the QC process as appropriate
- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e
- Regulatory Agency (RA), Central Independent Ethics Committee(IEC) and any other central
- Curriculum Vitae ofPage 3 10 authorities for the assigned country/countries
- Accomplishments ability to manage the team of direct reports maintaining very low level of eTMF and CTMS findings at running trials
Freelance, protocol designer, CRF designer, medical writer
05.2009 - 12.2015
- Regulatory expert, project manager, CRA at couple of local studies, incl
- Medical device studies
- Accomplishments successful conduct of designed trials, according the CRFs designed.
Country Manager
CHILTERN INTERNATIONAL CZECH REPUBLIC
05.2005 - 04.2009
- To create and maintain a database of local potential monitors
- To contribute to coaching new monitors on all aspects of the proper performance of their duties
- To manage monitors re monitoring of the correct completion of nonstudy-related reports and forms (e
- G
- Invoices and expenses reports, performance metrics reports etc & monitor the results.)
- To create and maintain a database of local investigators and sites
- To liaise with the Clinical Manager for CEE & Nordic Countries & Operations Director as appropriate
- To work in a timely manner in accordance with the agreed budget, under the supervision of Clinical
- Manager for CEE & Nordic Countries & Operations Director
- To carry out any other reasonable task, as requested by Operations Director or his/her line management, in order to ensure proper function of the Company office in Czech Republic and of the local team and many others
- Supervision of the work of the Czech office and the local team of CRAs/monitors
- Accomplishments Member of ACRP – holder of “Best Professional of the Year 2007”
Director of Operations, General Manager
INVERESK RESEARCH
08.1999 - 05.2004
- To manage within the limits of authority agreed from time to time, the operational and business functions for the clinical trials activities of IR in Czech Republic
- To maintain suitable premises for operations in Czech Republic and to assist in any negotiations with landlords and other organisations as appropriate
- To participate in selected aspects of study conduct e.g
- Monitoring
- To take responsibility for the security and safekeeping of Inveresks and clients equipment and other materials, including necessary archive facilities
- Project management and other aspect of the contract delivery
- To assist Inveresk in establishing new business enquiries and contracts for Phase II/III/IV activities in
- Czech Republic, Slovak Republic, Hungary
- Fully responsible, together with line manager and in accordance with agreed objectives, for financial performance and viability of the operations under my control
- Accomplishments opening and running business in Romania, Bulgaria, Croatia, Slovenia
- Title CRA
CRA
PHARM, OLAM INTERNATIONAL
08.1997 - 07.1999
- Responsible for training and controlling of the new monitoring staff
- Working with Inveresk Research International on two projects since 1997
- Maintaining contacts with all investigators and business development (past, present and potential)
- Curriculum Vitae ofPage 4 10
- Responsible for registration of new trials
- Maintaining the study documentation according the ICH-GCP
- Identification of new investigators
- Communication with regulatory office
- Identification of new study sites
- Responsible for initiation, monitoring and reporting of clinical trials
- Accomplishments
Education
Doctorate - Medical Doctor, Cardio-Metabolic Diseases;Dermatology;Endocrinology;Gastroenterology;Hematology;Immunology;Infectious Diseases.;Musculoskeletal;Neurology;Oncology;Ophthalmology;Respiratory
Charles University Prague, 1st medical faculty
06.1993
Skills
- Customer service
- Team leadership
- Time management
- Decision-making
- Verbal and written communication
- Complex Problem-solving
- Staff training and development
Languages
English
Professional Working
Czech
Native or Bilingual
German
Limited Working
Spanish
Elementary
Russian
Elementary
Slovak
Limited Working
Timeline
Manager of Global Regulatory Affairs
ICON, PRA Health Sciences
04.2020 - 11.2024
Regulatory Affairs Specialist
PRA Health Sciences
12.2015 - 03.2020
Freelance, protocol designer, CRF designer, medical writer
05.2009 - 12.2015
Country Manager
CHILTERN INTERNATIONAL CZECH REPUBLIC
05.2005 - 04.2009
Director of Operations, General Manager
INVERESK RESEARCH
08.1999 - 05.2004
CRA
PHARM, OLAM INTERNATIONAL
08.1997 - 07.1999
Doctorate - Medical Doctor, Cardio-Metabolic Diseases;Dermatology;Endocrinology;Gastroenterology;Hematology;Immunology;Infectious Diseases.;Musculoskeletal;Neurology;Oncology;Ophthalmology;Respiratory
Charles University Prague, 1st medical faculty
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