דרושים Senior Regulatory Affairs Professional ב-טבע ב-Croatia, Zagreb

As a part of Global procurement team, your responsibilities will include:

• Own new reporting solution by providing a single point of contact for all procurement related topics, provide training, proper documentation and align business requirements with IT
• Implement new reporting solutions and tools within Global Procurement to support Business needs
• Other projects/duties to be assigned as needed/appropriate. Examples may include process creation/enhancement, cross-functional team participation, etc.
• Regular (e.g. monthly) and ad-hoc data gathering, reporting, consolidation and analysis of the data to ensure high data quality
• Point of contact for external functions: such as Finance, Legal, Supply Chain etc. who requires data and analytics on Procurement information

• Work with Procurement, Finance and business leaders to develop, enhance existing and develop new cross-functional Reporting capabilities

Temporary contract - 1 year, with possibility to become permanent

• University degree in Business, Finance, or Engineering
• 3+ years of experience:
  • with DWH/BI systems, within Finance, Invoice, Payments, Planning and Procurement subject areas
  • with ERP system mainly Procurement and Financial modules, structure and processes
• Strong knowledge Reporting and analytics solutions (Power BI, QlikView or similar) and understanding of IT acumen
• Strong knowledge of SQL/PL SQL with hands-on experience
• Experience with advanced analytics projects is an advantage
• Solid understanding of procurement best practices, policies and tools
• Exceptional MS office skills, along with the ability to manipulate heavy sets of data and create concise and accurate reports
• Strong interpersonal skills including cross-functional teamwork in multi-cultural environment.
• Effective written and oral communication skills
• Strong analytical and reporting skills. Managing data and information to report KPI’s and update progress against program objectives.
• Ability to lead and influence without authority
• Strong in time management and organization

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Data Governance & Backbone Enrichment

• Lead and manage data governance activities for the R&D analytical backbone.
• Support enrichment efforts across both backend and frontend layers of the analytical backbone.

Digital Platform Ownership

• Be assigned to relevant digital platforms and areas of need, including tools within the Microsoft 365 suite (e.g., Power BI, SharePoint, Power Automate) and AI-related platforms.
• Ensure platforms are effectively deployed, adopted, and maintained to meet business requirements.

Stakeholder Collaboration

• Collaborate closely with SHMs, Digital Leads, and cross-functional stakeholders to ensure alignment, adoption, and usability of digital tools and platforms.
• Act as a liaison between IT and business units to translate strategic needs into actionable digital solutions.

Within the scope of responsibilities:

• Drive implementations and continuous improvement of digital capabilities across R&D.
• Excels at cross-functional coordination – Working with IT, business units, vendors, and leadership.
• Maintain and enhance digital assets such as dashboards, SharePoint sites, and automation workflows.
• Facilitate knowledge sharing and training to promote digital literacy and platform usage.
• Participate in strategic planning and intake processes for new digital initiatives.
• Familiarity with Jira, Confluence & Sprints agile methodology

• Bachelor’s degree in Business or Software Engineering, or equivalent combination of education and related experience
• 2-3 years of experience as a business analyst managing multiple small to mid-sized projects with an understanding of digital offerings, including Power Platform, RPA and ML / AI capabilities
• Computer skills, especially with Project management software (Planisware, Jira, and/or Confluence), Excel, Powerpoint
• Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions. Identifies and solves problems by gathering and applying information from a variety of sources
• Project management skills in planning, milestone tracking & reporting
• Delivery oversight skillset mindset
• Stakeholder Management capabilities and customer facing approach.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Providing legal support – in English – to drafting, reviewing, negotiating and generally supporting contracting activities with a global footprint.
• Providing guidance to junior lawyers and/or paralegals and other support staff.
• Completing special legal projects as requested for the benefit of the broader legal department.

• Qualified lawyer in at least one jurisdiction.
• At least 10 years of relevant legal experience earned in-house or at law firms (focused on supporting contracting activities in English), preferably in a multicultural and interdisciplinary environment.

• Excellent communication skills.
• Strong client service orientation with the ability to respond quickly and pragmatically to urgent situations.
• Ability to build strong relationships internally with both legal colleagues and business stakeholders.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook); experience with document automation and collaboration platforms is a plus.
• Familiarity with legal technology systems such as contract lifecycle management (CLM) platforms, e-signature tools (e.g., DocuSign), and matter management systems.
• Experience in the Pharmaceuticals and/or Life Sciences sector is a plus.
• Exposure to or having worked in a shared services environment is a plus.
• Multi-cultural experience is a plus.
• Ability to work in one or more additional languages (e.g. German, Spanish, French, Italian, Russian, etc.) is a plus.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Requirement Analysis: Analyze business requirements and perform thorough Impact analysis
• Solutioning & Design: Solutioning for new SAC (SAP Analytics Cloud) planning application implementations and also for enhancements to existing planning applications.
• Prepare High level and detailed design specifications related to SAC Planning model and Import/Export interfaces from/to SAP BW/Datasphere/Oracle databas
• Collaboration: Collaborate with Technical, Stakeholder management and Cross functional teams
• Delivery : Contribute and lead the delivery of SAC Planning application Implementation, enhancements and Interface developments
• Project Status updates : Timely updates of the ongoing development tasks and incident resolution status to the management and concerned teams
• Technical Ownership : Assume technical ownership ensuring tight control over all the technical aspects of the application and adhering to established governance and best practices
• Project Support: Monitor Service Now incidents, JIRA tasks and track them to closure
• Technical Documentation: Prepare and maintain the technical documentation and user guides

• : Bachelor's or Master's degree in Finance, Accounting, Business Administration, or Information Technology.
• 12 + years of experience in the areas of Planning and Analytics
• Minimum 3-4 end to end Planning/Budgeting/Forecasting implementation experience using SAC (SAP Analytics Cloud) Planning
• Strong Understanding and experience of implementing Financial Planning and Standard Financial statements : P&L, Balance Sheet and Cash Flow is a must
• Experience in developing Advanced formula, Data actions
• Extensive experience in Stories and dashboards with rich visualization.
• Experience with setting up User Security in SAC
• Experience with Inbound and Outbound data integrations/interfaces with upstream and downstream systems is a must
• Experience with scripting for Analytical applications is an added advantage
• Strong excel skills
• Data reconciliation and troubleshooting skills
• Hands-on experience with SAP BW / SAP Datasphere
• Hands-on experience in developing simple to Medium complexity SAP HANA Calculation views
• Good Understanding / Hands-on experience in SQL is an added advantage
• Past experience in other Planning tools like BPC standard, BPC Embedded , BW-IP, Hyperion Planning etc. is an added advantage
• Client interfacing skills and experience in interfacing with Senior management and Business users/end users
• Self motivated and quick learner and has the ability to adapt to highly dynamic environment

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Design and execution of Extractable and Leachable (E&L) studies, incorporating LC/UV/MS or GC/FID/MS analytical techniques.
• Development and validation of analytical methods incorporating Mass Spectrometry detection (LC/MS or GC/MS).
• Support the characterisation of polymer materials used in medical devices and packaging, including inhalation and injectable drug products, for both small molecules and biopharmaceuticals.
• Assist in the interpretation of Mass Spectrometry (MS) data as part of compound identification studies.
• Instigate and drive scientific and technical investigations developing multidisciplinary approaches to solve wide ranging and complex problems.
• Compilation and review of detailed technical documents.
• Deliver high levels of customer service (both internal & external)

• Temporary (maternity leave cover)

• Degree, Masters or PhD qualification in Chemistry (or related discipline), with minimum 3 year’s work experience with analytical method development and validation.
• Experience in analytical method development and validation with mass spectrometry is highly desirable.
• Experience with Empower and MassHunter software is highly desirable.
• Excellent communicator (both oral and written).
• Experience of working to current Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) and implementing policies and procedures in line with regulatory guidelines.
• Knowledge of regulatory and compliance requirements.
• Good planning and organising skills, adaptable to changing priorities.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Manager, Complex Gx, Regulatory Affairs is responsible for the supervision, preparation, critical review, and submission of high quality regulatory submissions—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager serves as team leader for projects and is responsible for overseeing the evaluation of change controls. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance’s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The primary responsibilities of the Manager include the preparation and compilation of original applications, amendments, deficiency responses, postapproval supplements, and training of regulatory staff.

• Independently support the preparation, review, and compilation of regulatory submissions (original applications, supplements, and responses) for sterile complex generic products.

• Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Other projects and duties as required/assigned.

• Pharm D/BS in a scientific discipline or equivalent education and related experience

• Master’s degree in RA/QA discipline, preferably in Pharma.

• Minimum 8+ years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience with sterile products required, coupled with 2 years analytical/QC, R&D/laboratory or production experience is preferred.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates excellent verbal and written communication skills.
• Shares concepts, ideas, information, and suggestions with management, peers and others.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Your responsibilities will include:

• Providing support in HR related matters to Teva employees based in Latin America.
• Entering and maintaining employees’ data in the SuccessFactors system (following the employee life cycle from hire to retire).
• Working closely with the Payroll department ensuring payroll data accuracy.
• Acting as a liaison between the employee and HR managers in order to resolve queries and issues.
• Acting as a first point of contact via ticketing system responding to a broad range of HR related inquiries.
• Ensuring integrity of HR databases and any downstream impact with any/all changes

• Fluent verbal and written communication in Spanish and in English
• Good knowledge of MS Office tools (Excel, Word)
• Experience of working in similar administrative jobs is desirable
• Customer and team oriented
• Willingness to work in an international environment

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.