Regulatory Process Coordinator

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)

Duration: till the end of March 2026

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

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

Desirable:

• Degree in Science/Pharmacy/Nursing field

• Knowledge of Regulatory operating model and organisation

• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry

• Experience of working with Procedural documents

  
  

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

Only for COW

• Life insurance

• Bonuses for Personal Events

• Day off for volunteering