Grzegorz Kojro

• Built relationships with customers and community to establish long-term business growth.
• Achieved goals and service targets
• Resolved problems with high-profile customers to maintain relationships
• Collaborated with upper management to implement continuous improvements and exceed team goals.
• Data management oversight.
  Act as Deputy of CDM Cluster Lead EU/AFME.
  Liaise with regional Business Units strategists, and any other applicable
  partner lines at local (clinical, safety and medical area among others).
• Coordinate the issuing of the reports and metrics as per need to evaluate
  team performance and data entry compliance.
  • Direct team managment.
  Develop key performance indicators in order to ensure accurate and timely
  execution of improvement initiatives and guarantee increased compliance
  in relevant processes.
  • Develop buisness processes, working instructions, SOP's and playbooks.
  Contribute to evolving data management & serve as a change agents with
  regional contact.
  • Coordination rollout of SCC process in AFME countries.
  Coordination rollout of SCC process for CP products. In this position I
  gained deep knowledge about cooperation with EMA.
  • Leading RPS Notifications Sub team.

• Led projects by coordinating schedules, organizing resources and delegating work to meet deliverable and timeline requirements.
• Conducted independent technical reviews of current processes and records to proactively identify and correct process and system issues.
• Supported department leadership in implementing new policies, procedures and controls.
• Oversaw work of junior personnel, helping to motivate strong performance and improve overall knowledge with focus on mentoring and coaching.
• Develop key performance indicators in order to ensure accurate and timely
  execution of improvement initiatives and guarantee increased compliance
  in relevant processes.
  •
  • Develop buisness processes, working instructions, SOP's and playbooks.
  Contribute to evolving data management & serve as a change agents with
  regional contact.
  • Coordination rollout of SCC process in AFME countries.
  Coordination rollout of SCC process for CP products. In this position I
  gained deep knowledge about cooperation with EMA.
  • Leading RPS Notifications Sub team.

• Maintained and archived regulatory paperwork.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Prioritized project-related tasks to efficiently complete essential tasks.
• Prepared and submitted regulatory file applications and supporting documentation.
• Practices in all countries that the company is exporting to.
  Preparing submissions of license variations and renewals to strict
  deadlines.
  Monitoring and setting timelines for license variations and renewal
  approvals.
  • Advising scientists and manufacturers on regulatory requirements.
  • Working with specialist computer software and resources.
  • eCTD publishing.
  • Advising and inform on submission planning.
• Liaising with regulatory, manufacturing and other parties as appropriate,
  to ensure the product packaging and associated information is updated
  and maintained in accordance with product licenses in international
  territories.
  •Ensuring that a company's products comply with the regulations of
  authorization bodies.
  •Implementation of QMS, eCTD publishing, data repository, regulatory
  information manager software to the company and department.
  Key person of publishing, data repository, regulatory information manager
  software (training end users worldwide).
  Administration of RIM system.
  • Writing of CTD modules (CMC module 3).
  Being part of CMC change control (assessing changes in manufacturing
  place from Regulatory point of view).
  • Internal auditor (compliance with SOP).
  Experience with registration of drugs in EU, and non-EU markets (Mideal
  East countries).
  • Checking and acceptance of mock-up and artwork.

• Validation of the submitted dossier for a DCP and MRP procedures
• Leading the process of registration of drug in DCP or MRP procedure
• Keeping abreast of international legislation guidelines

• Followed all company policies and procedures to deliver quality work.
• Listened and responded to customer requests and forwarded necessary information to superiors.
• Interpreted clients' needs and introduced services to fit specific requirements.
• preparation and edition of short description of drugs in the books for
  doctors