Experience

• 

  Gsk services sp. z.o.o

  Nov 2008 - Sept 2013

  Junior regulatory executive (gpar: gobal post approval registration)

  • Preparation, of variations, renewals, first registrations and administrative documents supporting the appropiate changes for international markets• Dossier despatch to LOCs (clients), response to questions creation if required: EU markets, Asean, Arabic, Latin America, Japan, South Africa, South Korea. Knowledge of international markets regulations.• Registration and renewals process coordination for products transferred to GSK Pharmaceuticals S.A. Poznań (Network Change Transfers)• Regulatory support for new products introduction projects• Regulatory documentation assessment within transfer process – transfer ‘like for like’/ not ‘like for like’ (regulatory variation identification acc. to guidance)• Implementation managing in aspect of: regulatory strategy, milestones in project schedule, team management (shopping list completion, demand switch - first supply, artwork process)• Continuous cooperation with Main Pharmaceutical Inspector in aspect of Certificate of Pharmaceutical Product forms• Cooperation with Embassies in aspect of documents legalization process according to specific markets requirements• Cooperation with LE (clients) on markets: MENA/Arabic, ASEAN, EU, CEE, CARICAM/Latina • Polish Pharmceutical Law; EMEA and FDA requirements familiarity• Support for dossier harmonisation process (Refferal Art. 30) for products registered on 29 EU markets • Site Registration Forms for MENA/Arabic markets preparation• Regulatory procedures knowledge: MRP, CE, CD (Mutual Recognition, Centralised and Decentralised procedure)• Regulatory requirements for API’s (Active Substance) knowledge ((EDMF/CEP; USDMF)• Establishing of quality requirements for raw materials and products transferred within Global Supply Network project • Medical samples dispatch: customs and exportation procedures knowledge Show less

• 

  Glaxosmithkline pharma gmbh

  Nov 2013 - Nov 2017

  • Coordination of registration processes for products transfered to Poznan GMS (factory/site)• Comply with GMP, QMS and pharmacutical law standards • Identification of potential EHS (Environment, Health and Safety) risks, EHS risks’ managment and escalation • QMS and quality standards training performance• Preparation, opinion giving and approval of quality documentation• Attendence in quality incidents, deviations, CAPA process, postaudit recommendations and complaints • Participation in selfinspections• Participation in internal and external audits• SAP system basic knowledge and use Show less

  • Quality Assurance Specialist

    Oct 2013 - Nov 2017

  • Registration Specialist in Transfer and Technology Department

    Nov 2013 - Oct 2015
• 

  Ivowen limited

  Dec 2017 - Feb 2019

  Senior regulatory specialist

  • Preparing and filling the necessary forms for the National/CP/DCP/MRP registration of the products with the relevant Regulatory Authorities• Maintain communication with the Regulatory Authorities of the RMS for the initiation of the procedure• Module 1, 2 and 3 preparation for the National/CP/DCP/MRP in consultation with the client• Submission of the dossier to the competent Regulatory Authorities in the National/CP/DCP/MRP• Follow up with the competent Regulatory Authorities in the national MS, EMA or the RMS and CMSs during the (National/CP/DCP/MRP) procedure• Preparation and submission of the response documents during the National/CP/DCP/MRP procedure and follow up until the conclusion obtained• preparation and submission of response documents during the (NATIONAL/CP/DCP/MRP) procedure in the required electronic format (NeeS)• follow up with the competent Regulatory Authorities in the national MS, EMA or the RMS and CMSs until the end of the NATIONAL/CP/DCP/MRP;• Regulatory strategy recommendations Show less

• 

  Getinge

  Feb 2018 - Feb 2019

  Vigilance specialist surgical workflow

  Vigilance Specialist SW (Surgical Workflows) reponsibilties:• Reportable and standard complaints handling• Conducting investigations for medical devices, acting as a safety officer• Reportable field actions coordination. Carrying out the process efficiency and coordination of field actions in the market which are associated with the risk, in collaboration with local manufacturers and involved SSU’s, in line with the field action procedures• Control and approve on regular basis cross organizational complaint audits in order to ensure correct classification and handling• Communication with the Authorities Show less

• 

  Iqvia

  Mar 2019 - now

  •Directs, oversees and manages complex regulatory projects, ensuring quality deliverables on time and within budget. Ensures that all project work is completed in accordance with SOPs, policies and practices.•Project Manager for a large stand-alone program, involving several regulatory or technical deliverables globally. Undertakes risk analysis, management and contingency plans, as appropriate.•Manages meetings with Regulatory Agencies.•Provides mentorship to junior colleagues and advises others on many regulatory document types.•Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations.•Leads and manages regulatory activities related to CMC and asset transfers/projects following established organizational processes and procedures.•Manages regulatory projects planning, execution, and monitor & control efforts, report on progress, manage project closing as required.•Works with project leadership, team and other stakeholders preparing project plans and associated agreements.•Organize, attend and facilitate cross-functional and regulatory meetings as needed.•Coordinate tracking and delivery of the project strategic plans including preparation of regulatory submissions, provide status updates as required.•Lead and/or assist in Regulatory Risk management efforts for the assigned projects.•Ensure collaborative relationship with the assigned project internal and external stakeholders.•Responsible for timely and seamless delivery of the assigned work. Show less •Leads and manages regulatory activities related to CMC and asset transfers/projects following established organizational processes and procedures.•Manages regulatory projects planning, execution, and monitor & control efforts, reports on progress, manages project closing as required.•Works with project leadership, team and other stakeholders preparing project plans and associated agreements.•Organizes, attends and facilitates cross-functional and regulatory meetings as needed.•Coordinates tracking and delivery of the project strategic plans including preparation of regulatory submissions, provides status updates as required.•Leads and/or assists in Regulatory Risk management efforts for the assigned projects.•Ensures collaborative relationship with the assigned project internal and external stakeholders. Show less • Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;• Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;• Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;• May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;• May prepare and deliver regulatory training to IQVIA small groups or individuals;• Performs other tasks or assignments, as delegated by Regulatory management; Show less

  • Senior Regulatory Affairs Manager

    Apr 2023 - now

  • Regulatory Affairs Manager at IQVIA

    Apr 2019 - Mar 2023

  • Senior Regulatory Affairs Officer

    Mar 2019 - Apr 2019