Compliance

• Standardises and enhances control testing methodologies and practices to ensure meets stakeholder expectations
• Partners with relevant business units and control owners to document processes and assess the appropriateness and completeness of the key risks and controls identified
• Controls testing execution including walkthroughs, design, and operating effectiveness testing
• Escalates and communicates findings from testing to stakeholders
• Analyse the severity of control deficiencies and their impact
• Validate and monitor remediation of issues through assessment of the corrective actions performed
• Compile, manage, submit and socialize required monthly, quarterly or annual reporting including test results, dashboards and/or testing issue remediation status
• Support Risk and Control Self-Assessments (RCSA)
• Assist with control projects, operational and/or corporate risk initiatives, where directed
• Assist with the adoption of AI into the role, including testing, reporting and monitoring

Senior Risk and Compliance Associate

• Support responses to customer questions, assess contracts and support tender processes to enable the way we explain information security
• Assist with ad hoc tasks, e.g. internal compliance reviews, updating of the risk assessment and annual assurance plan
• Report on progress/follow up on agreed mitigating tasks in term of IT security to management
• Daily operation and business support related to our IT Security

Compliance Specialist

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Senior Regulatory Affairs Associate – CMC Biologics, Vaccines

• Define and own the Technology Compliance & Quality Governance strategy.
• Serve as a trusted partner and senior escalation authority for executives.
• Oversee the end-to-end delivery and lifecycle of defined functions (e.g., QMS).
• Lead enterprise-wide technology risk assessments and compliance maturity evaluations.
• Build, coach, and develop a high-performing global team of professionals.
• Define success metrics (KPIs/OKRs) and leverage data analytics for improvements.
• Manage the immediate team's budget and resources.

Head of Compliance and Quality Governance

• Support monitoring activities (data collection)
• Support monitoring CAPAs
• Support transfer of value reporting
• Manage annual FMV updates
• Preparation, communication and monitoring of Data Privacy Notice (DPN)
• Support compliance trainings (systems)
• Support with systems by being a super user (e.g. Veeva, SOOS)
• Supporting Compliance Director and Senior Compliance Manager with various tasks

Junior Compliance Specialist, CEE

• Support daily trade compliance inquiries from warehouse teams, brokers, and freight forwarders.
• Ensure compliance of import and export activities with applicable domestic and international regulations across Radiometer operating companies.
• Manage government-related requirements, including license applications and communication with authorities (e.g., CITES, USDA where applicable).
• Execute key elements of the trade compliance program, including classification, valuation, and broker coordination and country of origin issues.
• Support audits, self-testing activities, and implementation of process improvements and corrective actions.

Global Trade Compliance Specialist

• Risk and Compliance oversight in RDP.
• Set, deploy and maintain meaningful KPIs/metrics that enable compliant organization and drive continuous improvement programs.
• Own and drive management monitoring process and have oversight of other relevant controls (e.g. processes/standards, training, etc.) if appropriate.
• Support RDP responsible in risk management (identification, control strategy, assessment of residual risk and prioritization).
• Coordinate regulatory intelligence monitoring (regulation/consultation) for GVP, GCP, GLP regulatory requirements.
• Establish and maintain appropriate structures and processes of risk management (SOP, templates, risk register, charter) and train RDP/R&D responsible accordingly.
• Collect and consolidate relevant information from risk owners into risk management forum to support overall compliance and risk assessment.
• Be the contact point between Enterprise Risk & Audit and R&D functions.
• Articulate and communicate risk management principles/model within R&D.
• Develop supportive materials (templates, training, etc.) to help RDP and R&D functions in Compliance and Risk management.

Global R&D Risk and Compliance Manager

• Update the regulatory tracking system (i.e. InSight) and/or the labeling information tracking system (i.e. LIFT) based on data entry requests received from Data Owners (e.g. EMEA Local Operating Companies [LOC], Cross-Regional Operations & Strategic Support teams (C-ROSS), EMEA Regulatory Affairs Therapeutic Areas) for a variety of regulatory procedures, including but not limited to: Marketing Authorisation Applications, License Renewals, Labeling variations, Chemisty Manufacturing and Controls (CMC) variations, License Withdrawals/Transfers/Expiries.
• Scrutinize data entry requests with Data Owners and instruct Data Owners as needed, to ensure consistency and quality of data entered in InSight and LIFT.
• Follow-up with Data Owners to ensure completion of the assigned data entry request.
• Maintain a good understanding of all Regulatory procedures and the corresponding Internal Global Job Aids and Procedural documents to ensure that requested data are timely and accurately entered in the applicable regulatory systems.
• Collaborate effectively with the Data Owners and ensure data owner alignment with data entered on their behalf.
• Support Data Owners with guidance, training, instructions on the process and requirements for maintaining InSight and/or LIFT data.
• Support other team members in data integrity activities (e.g. onboard newcomers, act as Subject Matter Expert (SME)).
• Support GRA EMEA with ad hoc reports and data upon request, e.g. in relation to audits, inspections, quality investigations.
• Coordinate data verification activities and queries with Data Owners upon request.
• Contribute to process development and process improvement activities in EMEA and globally as needed (e.g. direct involvement into projects per expertise and career development interests).
• Align with team members to ensure data entry backup capabilities during vacation and holiday periods.

Regulatory Affairs Professional, Data Integrity

• Przygotowywanie dokumentacji rejestracyjnej produktów leczniczych na potrzeby rejestracji głównie w krajach poza Unią Europejską (tj. UA, MD, AZ, GE, TJ, TM, MN) zgodnie z obowiązującym prawem
• Prowadzenie procedur rejestracyjnych (dopuszczenie do obrotu, re-rejestracji, zmian porejestracyjnych, notyfikacji) zgodnie ze strategią Firmy
• Współpraca z innymi strukturami Grupy Polpharma, jej partnerami oraz zagranicznymi przedstawicielstwami
• Udział w zespołach projektowych
• Monitorowanie postępów prowadzonych procesów rejestracyjnych oraz raportowanie w systemach wewnętrznych
• Identyfikacja ryzyk rejestracyjnych oraz proponowanie działań mających na celu ich minimalizację

Regulatory Affairs Specialist – Fixed-Term Contract

• Develop import/export strategies for international projects
• Ensure compliance with global trade regulations
• Oversee trade activities and manage regulatory risks
• Collaborate with cross-functional teams to achieve project objectives

Global Trade Compliance Leader

• Establish and operate governance frameworks across full transition lifecycles (feasibility through stabilization).
• Support steering committees and project boards while enforcing strict delivery methodologies.
• Identify, log, and mitigate critical risks and interlocks across multiple cross-functional workstreams, driving swift escalations and resolutions.
• Validate that enterprise processes align with internal controls, corporate policies, and data protection regulations (e.g., GDPR), supporting secure data migrations and system access.
• Maintain structured documentation and decision logs to support internal/external audits.
• Deliver transparent, KPI-driven status reporting to senior executives.
• Balance aggressive project timelines with stringent compliance mandates, partnering seamlessly with executive leaders across matrixed organizations.

Governance & Compliance Specialist

• Risk and Compliance oversight in RDP
• Set, deploy and maintain meaningful KPIs/metrics that enable compliant organization and drive continuous improvement programs.
• Own and drive management monitoring process and have oversight of other relevant controls (e.g. processes/standards, training, etc.) if appropriate.
• Support RDP responsible in risk management (identification, control strategy, assessment of residual risk and prioritization).
• Coordinate regulatory intelligence monitoring (regulation/consultation) for GVP, GCP, GLP regulatory requirements.
• Establish and maintain appropriate structures and processes of risk management (SOP, templates, risk register, charter) and train RDP/R&D responsible accordingly.
• Collect and consolidate relevant information from risk owners into risk management forum to support overall compliance and risk assessment.
• Coordinate risk management forum (i.e., CMO ROC and R&D CRF) as secretariat.
• Be the contact point between Enterprise Risk & Audit and R&D functions.
• Articulate and communicate risk management principles/model within R&D.
• Develop supportive materials (templates, training, etc.) to help RDP and R&D functions in Compliance and Risk management.

• To ensure and enable compliant organization and robust inspection readiness by Having Risk and Compliance oversight in RDP organization.
• Ensuring appropriate Risk Governance of risks owned/monitored by R&D Head and CMO through the coordination of risk management forum (i.e., CMO ROC and R&D CRF).
• Providing expertise and support (Center of Excellence) to RDP and R&D functions in areas of Risk, Compliance and Management Monitoring.
• Set, deploy and maintain meaningful KPIs/metrics that enable compliant organization and drive continuous improvement programs.
• Own and drive management monitoring process and have oversight of other relevant controls (e.g. processes/standards, training, etc.) if appropriate.
• Support RDP responsible in risk management (identification, control strategy, assessment of residual risk and prioritization).
• Coordinate regulatory intelligence monitoring (regulation/consultation) for GVP, GCP, GLP regulatory requirements.
• Establish and maintain appropriate structures and processes of risk management (SOP, templates, risk register, charter) and train RDP/R&D responsible accordingly.
• Collect and consolidate relevant information from risk owners into risk management forum to support overall compliance and risk assessment.
• Coordinate risk management forum (i.e., CMO ROC and R&D CRF) as secretariat.
• Be the contact point between Enterprise Risk & Audit and R&D functions.
• Articulate and communicate risk management principles/model within R&D.
• Develop supportive materials (templates, training, etc.) to help RDP and R&D functions in Compliance and Risk management.

• Act as the primary point of contact for investigative sites in Poland, ensuring clear and proactive communication
• Lead and manage country-level regulatory and start-up activities, including site activation processes
• Prepare, review, and submit EU CTR (Part II) applications via CTIS, ensuring compliance with Polish regulations
• Perform and manage country-specific ICF adaptations, including review, localization, and alignment with protocol and regulatory requirements
• Coordinate and execute Essential Document Package (EDP) activities, including: Collection, review, and tracking of essential documents; Quality control (QC) of site and regulatory documents; Ensuring completeness and readiness for regulatory green light
• Manage communication with sites to support document collection, submissions, and activation timelines
• Liaise with Ethics Committees, Competent Authorities, and internal stakeholders to facilitate approvals
• Support responses to RFIs (Requests for Information) and manage submission follow-ups
• Maintain and update CTMS, TMF, and tracking systems with accurate and timely information
• Review and ensure readiness of site activation packages / Green Light Packages
• Track and report site activation progress, timelines, and KPIs
• Ensure all activities are performed in compliance with ICH-GCP, EU CTR, and Polish regulatory requirements

Regulatory & Site Activation Specialist

• Proactively identify, assess, and mitigate risks across all IT systems, operations, and project lifecycles
• Map ITIL processes and SOX controls to global governance standards, prioritizing automated controls to increase efficiency
• Plan, execute, and monitor periodic control activities to maintain compliance
• Implement best-practice risk assessment strategies
• Guide product teams in integrating compliance requirements early in the development lifecycle
• Drive refinement of compliance frameworks and risk management processes
• Ensure minimal disruption to critical IT services and business operations
• Identify vulnerabilities and assess risks to establish recovery strategies (RTO/RPO)
• Develop, document, and regularly test DR plans to ensure resilience
• Lead cross-departmental efforts for a unified response
• Integrate new technologies (e.g., AI in monitoring) into recovery systems
• Lead, mentor, and develop the Risk & Compliance team

Senior IT Risk & Compliance Manager

• Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions
• Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions
• Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution
• Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging
• Monitoring changes in the regulatory environment and providing guidance on potential impact to programmes and submissions
• Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes

Regulatory Scientist

• Prepare, review, and submit regulatory dossiers (eCTD) for Marketing Authorisations, variations, and renewals in the EU and worldwide
• Assist in developing and implementing regulatory strategies for new and existing products
• Coordinate and prepare responses to queries from regulatory authorities
• Collaborate with cross-functional teams and external partners
• Support lifecycle management activities and maintain regulatory data
• Work in a multinational and multilingual environment, collaborating with global teams, partners, and B2B clients across different geographies and cultures

Regulatory Affairs Specialist

• Channel Partner Compliance: Implement robust policies for engaging third-party distributors, partner with business leaders to manage and monitor channel partner risks (including resolving red flags) and conduct due diligence and approvals in line with company policies
• Customer Interactions: Implement robust policies for customer interactions, partner with stakeholders to ensure compliant approval of high-risk activities and meet all applicable local transparency reporting requirements
• Auditing and Monitoring: Execute the Auditing and Monitoring plan based on identified risk areas by applying insightful analysis of selected transactions and recommending suitable countermeasures where there are audit findings
• Training & Communications: Deliver effective legal and compliance training and communication to both business users and 3rd parties, and conduct train the trainer sessions as appropriate
• System support: Management of global legal and compliance systems including user support and user training, applying data analytics to monitor correct usage and compliance with the policy and system maintenance and improvement tasks

Commercial Compliance Manager

• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
• Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff.
• Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements
• Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff

Senior Manager, Regulatory Affairs

• Follow company policies/standards to determine if activities or transactions are non-compliant/potentially suspicious and action as appropriate
• Ability to work/investigate alerts in a fast-paced environment while maintaining high quality standards
• Undertake ad-hoc project work and Financial Crime program enhancements
• Work closely with our Financial Crimes team to stay up to date on current industry standards and regulatory requirements
• Work in collaboration with cross-functional teams across the organization

Compliance jobs in Poland

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Senior Risk and Compliance Associate

Compliance Specialist

Senior Regulatory Affairs Associate – CMC Biologics, Vaccines

Head of Compliance and Quality Governance

Junior Compliance Specialist, CEE

Global Trade Compliance Specialist

Global R&D Risk and Compliance Manager

Regulatory Affairs Professional, Data Integrity

Regulatory Affairs Specialist – Fixed-Term Contract

Global Trade Compliance Leader

Governance & Compliance Specialist

Global R&D Risk and Compliance Manager

Global R&D Risk and Compliance Manager

Regulatory & Site Activation Specialist

Senior IT Risk & Compliance Manager

Regulatory Scientist

Regulatory Affairs Specialist

Commercial Compliance Manager

Senior Manager, Regulatory Affairs

Compliance Analyst I