Compliance

• Acquire and maintain parallel trading licenses, including dossier preparation, submissions, and lifecycle management
• Prepare and proofread packaging materials, artwork files, mock-ups, item lists, and regulatory documentation
• Communicate with competent authorities and stakeholders across assigned markets
• Participate in continuous improvement initiatives and optimization of processes and systems
• Support onboarding and training of colleagues within the team
• Evaluate regulatory legislation changes and contribute to operational implementation
• Participate in projects as an operational SME within Regulatory Affairs
• Support maintenance of SOPs, working instructions, and guidelines

Associate Specialist, Regulatory Affairs

• Supervisar y coordinar la ejecución de formulaciones, fabricación, construcción de expedientes, registro de productos
• Asistir en el registro de productos (medicamentos humanos, dispositivos médicos, cosméticos, suplementos alimenticios, etc.)
• Asegurar el cumplimiento de las regulaciones (en regulaciones europeas y locales) para todos los productos de Cipla
• Compilación de eCTD
• Recopilar y evaluar datos científicos
• Preparar etiquetado, PIL, SmPC y maquetas de productos médicos
• Proveer asesoramiento estratégico durante el desarrollo de nuevos productos

Regulatory Affairs, Local QPPV – Embedded Solution

• Planning, coordination and control of industrial production and maintenance strategies.
• Management and execution of customs procedures for product dispatches.
• Handling export licenses requests and tariff classification of materials.
• Liaison with tax agency regarding Intrastat filings and other compliance requirements.
• Preparation of certificates of origin and export control documentation (EUC, CUD, CII, DUD, etc.).
• Ensuring compliance with legislation related to export of defense and dual-use materials.
• Process automation and continuous improvement in planning and trade compliance workflows.
• Collaboration with cross-functional teams to support production and logistics operations.

Industrial Planner – Trade Compliance Officer

• The Regulatory Expert – Ecotoxicology acquires knowledge of recent regulatory scientific advances in the area of Ecotoxicology and is able to translate these into ways to organize and prepare registration dossiers for conventional and biological plant protection products.
• The Regulatory Expert – Ecotoxicology oversees and is accountable for lower and higher-tier assessments requiring involvement of more junior Regulatory Ecotoxicologists.
• Primary responsibility stands with ecotoxicology dossier section writing for both active substances and formulated products dossiers
• Performs, the assessment of client ecotoxicological data (data gap analysis and preliminary risk assessments) for the active substance and/or product dossiers under the focus of appropriate and specific regulatory requirements.
• Supports the Section Leader the Regulatory Ecotoxicologists for preparation of comprehensive technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy and clarity of presentation of results.
• Supports the Section Leader in the preparation of strategies to assist clients in dossier preparation including experimental programs according to European and national data requirements.
• In collaboration with the Section Leader, and Regulatory Ecotoxicologists organises experimental work compromising requesting, quoting, monitoring and time scheduling in and outside the Eurofins Agroscience Services Group.
• Monitors standard lower and higher-tier as well as non-standard studies.
• In the frame of Study Monitoring, engages closely with Study Directors and keeps a close contact with the laboratories and all other relevant Regulatory groups (e.g. phys-chem & Analytical Methods).
• Supports clients in the frame of their dossier stewardship post-submission / dossier defence.
• In collaboration with the Section Leader and Principal Scientist compiles and maintains regulatory documentation and tools.
• In collaboration with the Section Leader organizes all project-related activities related to the area of Ecotoxicology under the most recent regulatory legislation requirements and scientific guidelines.
• Follows-up closely on latest developments in the regulatory fields related to ecotoxicology that are influencing the quality of the deliverables.
• In collaboration with the Section Leader identifies, analyses and proposes ways of implementation of relevant guidance documents in the preparation of regulatory documentation.
• Attends and actively participates in internal and external Ecotoxicology Conferences, seminars but also clients’ meetings whenever required.
• Supports on Producing Regulatory Science documentation (articles, posters, webinars, etc.) in the area of Ecotoxicology supporting marketing/sales activities.

Mid-Senior Regulatory Expert – Ecotoxicology

• Coordinate regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions
• Provide regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise
• Provide guidance to the client on submissions strategies
• Prepare/review core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance
• Prepare, manage, and track IRB/IEC submissions (including renewals); acts as the primary point of contact for the central IRB/IEC
• Peer review of documents and packages prepared by colleagues within the regulatory team
• Review regulatory documents and submissions created outside of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to RA and IEC
• Point of contact for regulatory body and IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams for all aspects related to study regulatory submissions
• Develop/review Master Informed Consent Form (ICF), as applicable, and Country ICFs
• Review site-level Informed Consent form documents as needed
• Prepare or review study-specific regulatory documents/forms
• Manage/oversee translations and requests with vendor
• Submit and track SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope
• Perform regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites
• Review country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements
• Participate in Kick-off meetings, client audits, and other project related meetings according to the company / client needs
• Submit documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation
• Communicate activities performed out-of-scope to project team members and provides them with budgeting details related to said activity
• Maintain high level knowledge about regulations in the area of company interest
• Participate in function and/or corporate initiatives and special project assignments
• Support Regulatory Country Intelligence activities
• Communicate/liaise with regulatory agencies/competent authorities and/or other regulatory or functional experts on designated regulatory activities as required
• May provide presentations, training or help to develop tools and processes for the Regulatory Team or other cross-functional teams
• Provide line management to direct reports, including new-hire orientation, professional development, performance appraisals, and employee counseling/mentoring
• Management and coordination of resources and workloads of direct reports
• Supports staff by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level
• Promote a positive work environment and motivate the team to achieve organization goals
• Participate in the hiring process of new employees
• Provide leadership and implement productivity improvements to ensure optimal utilization of resources
• Participate in process improvement initiatives

Line Manager, Regulatory Affairs

• Support Regulatory Affairs operations with a strong focus on documentation management and regulatory data maintenance
• Request and collect regulatory and technical documentation from suppliers and third-party manufacturers
• Verify that documentation is complete, consistent, and aligned with internal requirements
• Classify, archive, and maintain documents in internal systems following established procedures
• Ensure traceability, version control, and proper documentation lifecycle management
• Act as a point of coordination with internal stakeholders to follow up on missing or incomplete documentation
• Enter, update, and maintain data in internal regulatory databases and systems
• Ensure data accuracy, consistency, and integrity across platforms
• Perform regular data quality checks to identify gaps, inconsistencies, or duplications
• Support system updates, data clean-up activities, and continuous improvement of data quality
• Contribute to audit readiness by ensuring documentation is complete, structured, and easily retrievable

Regulatory Data and Documentation Specialist

• Lead and support the delivery of global compliance initiatives (e.g., development and deployment of training programs; drafting and updating of policies and related documents, including driving rollouts thereof; drive HCP end-to-end compliance; support governance improvements)
• Translate strategic priorities into structured workstreams and execution plans
• Drive coordination across multiple stakeholders and regions
• Support the development and evolution of key compliance tools and platforms
• Define and implement operational processes supporting tool usage
• Act as interface between business, Compliance and technical stakeholders
• Identify opportunities for process improvement, standardization and automation
• Support the development of scalable and efficient operating models
• Contribute to the continuous improvement of Compliance & Privacy Operations
• Support the development of reporting frameworks and dashboards
• Prepare structured inputs for leadership reporting
• Ensure consistency and quality of data and outputs

Manager, Compliance Programs – Operations

• Lead end-to-end management of tender and regulated opportunities, ensuring full compliance with legal, contractual, pricing, and governance requirements.
• Partner with Sales, Legal, and Finance to execute deals, validate pricing, mitigate risks, and maintain accurate, audit-ready commercial and tender documentation.
• Responsible for sales administration and contract lifecycle management, driving process optimization and the standardization of commercial practices across Europe through insights derived from CRM/ERP data.

Sales Admin, Tender & Contract Compliance Specialist – d/f/m

• Trabajar con equipos multidisciplinares en proyectos de riesgos IT, cumplimiento, control interno y auditoría.
• Participar en el análisis e implementación de soluciones GRC en grandes organizaciones.
• Colaborar con clientes nacionales e internacionales, con impacto real en su negocio.
• Desarrollar aplicaciones que amplíen funcionalidades GRC usando tecnologías modernas.
• Diseñar e integrar APIs en entornos SaaS y multiplataforma.
• Trabajar con metodologías modernas y procesos de integración continua.

Consultor GRC Tech

• Participación y ejecución de proyectos relacionados con servicios de gestión de riesgos y control interno
• Identificación de riesgos que afectan a la estrategia y objetivos de cumplimiento
• Diseño o revisión de procesos y sistemas de control interno
• Respuesta a regulaciones nacionales e internacionales
• Establecimiento de la función de auditoría interna
• Implementación de enfoques digitales en la gestión de riesgos

Senior Consultant – Governance, Risk & Compliance

• Gestionar la tramitación administrativa de variaciones regulatorias, incluyendo preparación de documentación, presentación telemática y gestión de tasas.
• Mantener y actualizar bases de datos, listados y documentación interna de la compañía.
• Gestionar la recepción y procesamiento de resoluciones, incluyendo comparación con solicitudes y solicitud de correcciones si aplica.
• Organizar y mantener el archivo de expedientes regulatorios y de farmacovigilancia (electrónico y físico).
• Realizar la revisión parcial de materiales de acondicionado, siguiendo checklists y documentación oficial.
• Introducir y gestionar datos de casos de farmacovigilancia en las bases de datos correspondientes.
• Dar soporte en tareas administrativas generales (gestión de facturas, órdenes de compra, organización de reuniones, preparación de documentación, etc.).
• Gestionar comunicaciones relacionadas con desabastecimientos, envíos de producto y solicitudes externas.
• Colaborar con distintos departamentos para garantizar la correcta gestión documental y cumplimiento regulatorio.

Administrativo/a de Regulatory Affairs y Farmacovigilancia – Pharma

• Independently conduct complex compliance investigations
• Develop and execute risk-based compliance monitoring plans
• Analyze investigation findings and monitoring results
• Partner with cross-functional stakeholders for seamless integration of outcomes
• Serve as a knowledgeable resource to team colleagues

Director, Compliance Investigations and Monitoring

• - Manage multiple concurrent projects, delivering high-quality, high-impact work that drives results for Anthesis clients.
• - Provide technical leadership and guidance to both clients and colleagues on leading standards and trends, integrating this expertise into projects, proposals, and service evolution.
• - Draft comprehensive reports and presentations that distill complex information into key messages to inform strategic decision-making.
• - Execute detailed regulatory deep-dives to help clients interpret and action critical requirements, future-proof their operations, and plan for new legislative initiatives.
• - Conduct regulatory readiness assessments focusing on existing and upcoming packaging frameworks.
• - Perform landscape reviews, including sustainable packaging regulations and competitor commitments.
• - Utilize data analysis to identify gaps or inaccuracies, developing well-reasoned approaches and assumptions to bridge them.
• - Lead and grow client relationships, acting as the primary point of contact and trusted advisor with a relentless focus on their sustainability success.
• - Develop and deliver high-impact proposals in collaboration with client managers, while also generating leads with existing clients through a deep understanding of their business goals.
• - Proactively monitor and analyze emerging trends in sustainable packaging, supply chains, and innovative materials, translating these insights into actionable client recommendations.
• - Collaborate with global experts to represent Anthesis at industry-leading conferences, fostering strategic connections and partnerships.
• - Drive the creation of innovative thought leadership content, transforming complex concepts into accessible and engaging materials for diverse audiences.

Senior Consultant – Regulations Expert, Packaging

• Framework Management: Maintain and improve our compliance posture for SOC 2 Type II and ISO 27001. Assist in the roadmap for future certifications (e.g., HIPAA, GDPR).
• GRC Automation: Administer our GRC platform (e.g., Vanta, Drata) to automate evidence collection and monitor control health in real-time.
• Audit Coordination: Lead external audit cycles, acting as the main interface between auditors and our internal technical teams.
• Customer Trust: Own the security questionnaire process. Build and maintain a 'Trust Center' or Knowledge Base to accelerate sales cycles by providing accurate security documentation to prospects.
• Risk Management: Conduct internal risk assessments and vendor security reviews to ensure our supply chain meets HappyRobot’s standards.

GRC Compliance Analyst

• Support European regulatory compliance for coatings and paints
• Ensure compliance with EU chemical regulations (REACH, CLP, and related legislation)
• Manage and maintain regulatory data in digital systems and databases
• Develop and continuously improve regulatory reports, dashboards, and tracking tools
• Conduct regulatory screenings and assessments to support product development and change-management activities
• Prepare and maintain regulatory documentation (SDS, labels, product notifications)

Regulatory Affairs Specialist

• Gestionarás proyectos de análisis de riesgos IT desde el punto de vista de confidencialidad
• Asesoramiento en materia de privacidad y seguridad de la información
• Liderarás proyectos en clientes referentes
• Emplearás herramientas de Data Loss prevention (DLP) y Cloud Access Security Broker (CASB) en implantación y operación de las mismas

Senior - Cyber Data Protection & Compliance

• Represent the Company before the Spanish local authorities (Bank of Spain, SEPBLAC).
• Responsible for all regulatory activities related to our Spanish license, through which the company provides services throughout all the EEA.
• Help the GHC in ensuring that implementation of the various local compliance programs is risk-based, efficient and consistent with the groupwide regulatory compliance framework. This includes drafting and maintaining global and local policies and processes.
• Coordinate internally and support the GHC in the implementation of regulatory programs, fundamentally at EEA and UK level (e.g. DORA, Operational resilience, Consumer Duty, Fraud prevention, AML, Sanctions etc.).
• Report to internal governance bodies on matters related to the group regulatory compliance framework and on Spanish local regulatory exposure.
• Arrange processes to assure that the regulatory compliance policies in place are well understood and respected by relevant employees and that the company is complying with all regulatory requirements everywhere it operates.
• Work alongside the Head of Global Operational Compliance to ensure close alignment.
• Subject matter expert on Regulatory Compliance for Spain.

Head of Regulatory Compliance – EU

• Ensure compliance with EU chemical regulations (REACH, CLP, and related legislation) by maintaining accurate and traceable regulatory data
• Manage and maintain regulatory data in digital systems and databases while developing, maintaining, and continuously improving regulatory reports, dashboards, and tracking tools
• Conduct regulatory screenings and assessments to support product development, reformulation, and change-management activities
• Prepare and maintain regulatory documentation (SDS, labels, product notifications) and evaluate regulatory/HSE data for new raw materials and suppliers
• Collaborate across regions to harmonize regulatory processes, support digitalization initiatives, and represent the company in relevant industry associations

• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.
• 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.
• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
• Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
• Provide support and guidance for Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.
• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
• Lead/manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Clinical Compliance Manager – FSP

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs

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