Aktualne oferty pracy związane z Regulatory Process Coordinator - Warszawa, Mazovia - NATEK

  • Project Coordinator

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat

    The Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Project Coordinator, you will take the lead to...

  • Senior Regulatory Affairs Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...

  • Senior Regulatory Affairs Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero Pełny etat

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...

  • Regulatory Reporting Associate

    7 dni temu

    Warszawa, Mazovia, Polska JPMorgan Chase Pełny etat

    The team is a multi-cultural team based in Frankfurt, Luxembourg, Mumbai and Warsaw, working as one to deliver best in class regulatory reporting to Deutsche Bundesbank & European Central Bank, under a strong and effective control framework. Capital monitoring and regulatory reporting activities are crucial from bank's perspective to run business in line...

  • Regulatory Scientist

    7 dni temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat

    Regulatory ScientistICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentThe Regulatory Scientist completes country and, or regional Clinical Trial...

  • Order Management Coordinator

    1 tydzień temu

    Warszawa, Mazovia, Polska FMC Corporation Pełny etat

    Order Management Coordinator – EMEA RegionFrom Day One, make a Difference – Join Our New Supply Chain Hub in WarsawAre you a detail-oriented multitasker who thrives in a fast-paced environment? FMC is looking for an Order Management Coordinator to oversee the full order lifecycle—from entry to delivery and invoicing. In this role, you'll be the key...

  • WFM Coordinator

    2 tygodni temu

    Warszawa, Mazovia, Polska TP Pełny etat

    TP is looking for new WFM CoordinatorWe are looking for someone who coordinates schedules, tracks performance, and helps ensure the right people are in the right place at the right time to meet business needs.Main duties:Coordinating the scheduling, forecasting and modification process across all LOBs;Supervising RTM on the project/LOB;Analysis of...

  • Regulatory Reporting Associate

    1 tydzień temu

    Warszawa, Mazovia, Polska Description The team Pełny etat

    DescriptionThe team is a multi-cultural team based in Frankfurt, Luxembourg, Mumbai and Warsaw, working as one to deliver best in class regulatory reporting to Deutsche Bundesbank & European Central Bank, under a strong and effective control framework. Capital monitoring and regulatory reporting activities are crucial from bank's perspective to run business...

  • Associate Regulatory

    5 dni temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat 146 800 zł - 272 500 zł

    Job OverviewDirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. This is a sponsor facing role.Essential FunctionsOversee the execution of Site Activation (including...

  • Senior Clinical Data Coordinator

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat

    The Senior Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed, and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with...

Regulatory Process Coordinator

3 tygodni temu

Warszawa, Mazovia, Polska NATEK Pełny etat

Job Description
Join Natek as a Regulatory Process Coordinator and work for a top global pharmaceutical company

This roles supports Process Directors and Associate Directors in managing key processes and projects. The role focuses on activities related to process implementation, communication, compliance, performance tracking, and inspection readiness. You will collaborate closely with teams across Regulatory Affairs and other functions to ensure smooth execution of process strategies, priorities, and governance, including maintaining and managing current procedural documentation.

This is a mid-level position providing support in updating regulatory procedures within the ECMS system, performing administrative tasks such as updating SharePoint Online (SPOL), and preparing reports using Excel and Power BI.

Location: Warsaw, Poland (3 days/week in the office)

Your Responsibilities

  • Collaborate with Process Directors and Associate Directors with enhancement of existing processes and procedural documents.
  • Author and collaborate with SMEs to deliver assigned Job aid and supporting documents and templates.
  • Working with the Process and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
  • Maintain and continuously improve key customer facing service solutions for Process guidance and document access (such as SPOL sites, portals for tickets, Q&A etc).
  • Coordinate specific tasks related to procedural document management to provide oversight to the regulatory process team
  • Using understanding of Regulatory processes and regulations to provide support to regulatory process team
  • Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation. Identify issues and risks in own area of work and propose options to mitigate them.
  • Ensure that appropriate, up-to-date records are maintained for compliance
  • Support activities for GVP, GCP, GRP and GMP audits/inspections
  • Support Delivery of improvement project assignments supporting the business
  • Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnership
  • Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships

Our Requirements

  • Strong administrative skills, including SharePoint Online expertise
  • Experience working cross-functionally and across cultures
  • Excellent written and verbal communication skills in English (min. B2 level)
  • Good attention to detail
  • Understanding or experience in the regulatory area
  • Experience working with documents that follow formal workflows
  • Ability to create and manage SharePoint Lists
  • Technical skills: Power Apps, SharePoint Online (SPOL), AI tools/solutions (e.g., Copilot, ChatGPT, AI Agents)
  • MS Office tools: Excel, SharePoint, PowerApps, AI tools
  • Soft skills: Collaborative and able to work effectively in an international team, calm, organised, detail-oriented and reliable

Benefits

  • Internal Mobility Program – enjoy many opportunities for career growth, job rotations, diversity of projects & technologies
  • Referral Program – enjoy cooperation with your colleagues and get a bonus
  • 5/10 Years NATEK Club – we offer long-term cooperation and celebrate each fifth- year cooperation anniversary with gifts
  • NATEK CSR Events & team buildings – enjoy our values: accountability, partnership and expertise and #workITwithus
  • Cafeteria
  • Medical Healthcare
  • Multisport Club Card
  • Technical and Personal training
  • Language courses

Additionally only for COW:

  • Life insurance
  • Bonuses for Personal Events
  • Day off for volunteering