Compliance

• 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 Analyst I

• Research technical characteristics of parts and products using SAP, customer or vendor websites, general internet searches, or other database tools.
• Under the supervision of the Assistant Trade Compliance Manager, assign and enter EU HTS, ECNs, and other relevant import/export information into SAP or MS Excel database.
• Create and manage product research files, including data entry, retrieval, and development.
• Sort, partition, extract, or add data items using SAP or MS Excel tools, including advanced functions such as Pivot Tables and VLOOKUP.
• Conduct audits and reviews of data entries for accuracy and completeness.
• Perform general administrative tasks to support the Global Trade Compliance Team, including file creation, entry reviews, and organizational tasks.
• Assist with product research file creation, data entry, and retrieval, ensuring accurate and timely updates.
• Ensure compliance with EU regulations for import/export, specifically in the classification of products and components.
• Assist in preparing reports and maintaining compliance documentation as required.
• May be assigned other duties as needed to support the Global Trade Compliance Team.

Senior Trade Compliance Specialist

• manage a team of compliance associates
• conduct effective performance management
• provide compliance guidance
• identify compliance risks
• ensure documents comply with regulatory and legal requirements
• develop action plans to manage compliance risks

Senior Commercial Compliance Manager, CEEMA Cluster

• Handle daily transactional tasks and department projects as assigned
• Determine accurate export/import classification data for standard and Engineered to Order (ETO) products
• Conduct analysis whether products qualify for different FTAs
• Support global Company program and projects, participate in global auditing of classification data
• Monitor inbound and outbound shipments for missing classification data
• Ensure compliance with Rockwell Automation global procedures
• Achieve results for monthly metrics

Classification Specialist, Import/Export Compliance

• Management of regulatory compliance and quality information.
• Support during commercialization to complete regulatory information.
• Support technical and new product developments to ensure understanding and compliance with legislative requirements.
• Approve product formulations, raw materials, and artwork to ensure compliance with legislative and customers' requirements.
• Respond to food legislation queries from internal customers.
• Interpret, evaluate, and apply regulations, industry standards and customer requirements to new and existing products.
• Managing projects, develop internal procedures, identify process improvements.
• Provide training to other departments and customers to share regulatory information.

Food Regulatory Compliance Analyst

• Drive the regional regulatory intelligence and policy strategy to support asset’s regulatory strategies
• Act as the regional lead for identification, prioritization and coordination of regulatory intelligence (RI) activities
• Provide senior subject-matter expertise to influence regulatory outcomes
• Foster the acceleration initiatives across the region anticipating opportunities and risk among relevant stakeholders
• Support capability building and training, ensuring effective adoption of new regulatory requirements and approaches

Regional Regulatory Intelligence Manager

• Lead the development and execution of regional regulatory strategy for assigned assets, aligned with global strategy and regional requirements
• Act as the single point of contact for regional regulatory, ensuring alignment across Global Regulatory Leads (GRLs), local regulatory teams, and cross‑functional stakeholders
• Provide regulatory expertise and market insight to anticipate risks, identify opportunities, and support decision‑making
• Drive delivery of submissions and approvals, ensuring timely, compliant execution across the region
• Collaborate with global and local teams to integrate regional requirements into development plans, including clinical, GMP, and submission strategies
• Ensure clear communication of regulatory plans, milestones, risks, and strategic implications to stakeholders
• Support continuous improvement, innovation, and knowledge sharing across regulatory teams

Regional Regulatory Manager

• Lead the development of appropriate business-focused, high-quality, timely regional regulatory strategy and its execution for assigned asset(s)
• Responsible for the development of optimal regional regulatory strategy and for its delivery according to plan
• Provide deep regulatory knowledge and international markets expertise
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective
• Proactively develop and implement regional regulatory strategy aligned with enterprise goals and local opportunities
• Represent Regulatory function in collaboration with regional stakeholders
• Drive early engagement with LOC RAs proactively sharing knowledge on clinical development programs and key project milestones

Regional Regulatory Affairs Director – International

• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• Provide training, coaching and mentoring to junior members of staff.

Senior Specialist, Regulatory Intelligence and Analytics

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director.
• Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.

Clinical Compliance Manager – FSP

• Conduct compliance monitoring related to Business Courtesies, Transparency, Training, and High-Risk Vendors.
• Assess adherence to internal processes, SOPs, Policies, and external industry guidelines.
• Document compliance monitoring results thoroughly and accurately.
• Network effectively with Compliance Officers and Standards & Governance Officers globally.
• Report compliance monitoring results on a regular basis.
• Provide effective governance support for the Compliance Program.
• Offer service-oriented support in interactions with various stakeholders.
• Provide training and informal guidance for team members.
• Demonstrate proficiency in handling complex samples.
• Investigate and analyze solutions, implementing them proactively.
• Take ownership of outcomes, ensuring quality results.
• Manage IT governance and data validation activities.

Senior Analyst, Compliance Monitoring

• Support daily continuous control monitoring activities by performing routine quality reviews of financial processes.
• Ensure that completed cases meet internal control standards.
• Prepare quarterly data summaries on reviewed case volumes for reporting.
• Perform daily quality reviews of financial transactions to verify compliance with established control procedures.
• Identify inconsistencies, missing information, or deviations from policy and record them accurately.
• Assist the Oversight & Monitoring Manager in preparing quarterly data on case completion volumes and monitoring results.

Junior Compliance Analyst – Maternity Cover

• Nadzór nad usługowym prowadzeniem rozliczeń podatkowych (CIT i/lub VAT) realizowanych przez dedykowanych specjalistów EY dla firm o międzynarodowym zasięgu i zdywersyfikowanym profilu działalności, ale także w firmach lokalnych lub dopiero planujących międzynarodową ekspansję
• Bieżące doradztwo podatkowe oraz realizacja wsparcia w zakresie specyficznych projektów podatkowych (bezpośrednio bądź z zaangażowaniem dedykowanych specjalistów EY)
• Współpraca z działami podatkowymi i finansowymi firm krajowych i międzynarodowych
• Aktywność na linii przedsiębiorstwo - urzędy skarbowe w zakresie kontroli podatkowych, skarbowych i czynności sprawdzających
• Koordynacja zagadnień podatkowych w ramach globalnej sieci spółek stowarzyszonych EY
• Rozwój biznesu poprzez wsparcie w pozyskiwaniu nowych klientów: w tym udział w spotkaniach z dyrektorami finansowymi i głównymi księgowymi
• Na tym stanowisku będziesz korzystać z narzędzi takich jak Microsoft Copilot oraz EY.ai EYQ - prywatnej i bezpiecznej platformy generatywnej AI, a także innych, unikalnych rozwiązań, często dostępnych tylko w EY.
• AI w EY wspiera codzienną pracę analityczną, pracę z danymi oraz tworzenie nowych rozwiązań, pozwalając skupić się na wnioskach, jakości i realnej wartości dla klienta.

Manager w zespole Global Compliance i Raportowania – Doradztwo Podatkowe

• Set the strategic direction and lead the delivery of Regulatory Vault Continuous Improvement.
• Oversee and optimize the technology infrastructure and digital platforms supporting regulatory and development operations.
• Partner with Tech and R&D Quality teams to ensure full GxP validation and prepare for regular inspections.
• Develop and execute strategies that integrate system operations, reporting and analytics, and support services.
• Work closely with cross-functional teams to ensure cohesive efforts in system operations and support services.
• Identify and implement innovative solutions and best practices to enhance system operations and reporting.
• Ensure all systems, reporting, and support services adhere to regulatory guidelines and standards.
• Lead, mentor, and develop a high-performing team to support GSK’s regulatory and development objectives.

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