Regulatory Affairs Associate Eu Labelling jobs at Teva in Croatia, Zagreb

• 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.

Responsible for leading and managing applications through the regulatory approval process, including preparation of Post Approval Submissions to Health Canada (HC), to obtain timely approvals. Work independently as a professional and keeps management informed of significant regulatory issues that affect assigned products/projects.

• Prepare, compile, review and submit high quality submissions for all post approval activities in accordance with Health Canada Regulations and corporate standards.
• Support the development and implementation of regulatory strategies for defined projects until approval and launch as applicable.
• Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
• Responsible for evaluating change controls for regulatory filing assessments in accordance with HC guidance documents. Subsequently prepare and ensure all timely post approval regulatory activities, as applicable.
• Keep current with the Teva work procedures, Health Canada Regulations/ Guidance as well as ICH regulations
• Business development assessments as applicable
• Other projects and duties as required/assigned

• Relevant degree in a scientific discipline
• Minimum 5-7 years in Regulatory affairs in post approval (EU/FDA with preference for HC) and overall pharma experience of 7-9 years
• Preferred, experience with sterile products.
• Excellent oral and written communication
• Excellent organizational 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.

• Develop and deploy TPM methodologies, including Autonomous Maintenance and Focused Improvement
• Align TPM rollout with TLMS principles and site maturity levels
• Design and implement global reliability tools (e.g., FMEA, RCM, Root Cause Analysis)
• Lead cross-site benchmarking and best practice sharing for both technical and operational excellence solutions
• Support collaboration with Global TLMS Pillar leaders and drive proper synergies and integration with the rest of the journey
• Support cultural change and capability building in maintenance and engineering teams
• Collaborate with site teams to implement TPM pillars and measure impact on Overall Equipment Effectiveness and downtime
• Define (in coordination with global Key performance Indicators program), align and track TPM-specific Key performance indicators and improvement program/roadmaps
• Conduct reliability assessments and develop action plans to address identified gaps
• Facilitate workshops and training sessions to build TPM capabilities across sites
• Provide on the floor, hands-on support to tackle major losses for the sites. Coaching the team on how to tackle losses using the TLMS tools
• Monitor and report on the progress of TPM initiatives and their impact on operational performance
• Establish good engineering practices related to maintenance as well as building community of practices and knowledge hubs
• Co-design TPM roadmap and TPM steps evolution for advanced problem solving tools like Work point analysis, Advanced condition based analysis tools, In depth analysis on recurrent breakdown, etc.
• Support in person and remote Pillar assessment as key enable for site phase progression
• The role requires more than 30% travel time

You are

• A leader with demonstrated success in leading reliability improvement initiatives across all sites
• Someone with an analytical mindset and ability to interpret data and drive decisions
• Strong facilitator with coaching skills for cultural and behavioral change trough remote and on site support
• Experienced in conducting training sessions and workshops for engineering teams
• Fluent in English

You have

• Bachelor’s or Master’s degree in Mechanical, Electrical, Industrial Engineering, or related field
• More than 10 years of experience in maintenance, reliability, Operational excellence or continuous improvement roles in a manufacturing environment in pharma, food, or automotive industry
• Hands-on experience with Total Productive Maintenance implementation and Lean Manufacturing systems and related pillars
• Deep knowledge of maintenance strategies and reliability engineering principles
• Experience with tools such as Failure Mode and Effects Analysis, Reliability-Centered Maintenance, Root Cause Analysis, and Overall Equipment Effectiveness analysis
• Experience in implementing predictive maintenance strategies using SAP PM
• Proven track record in managing global spare parts inventory and optimization project
• Lean Manufacturing or Total Productive Maintenance certification (i.e. from Japan institute of Plant Maintenance or Black belt); Certified Maintenance & Reliability Professional (CMRP) or equivalent is preferred
• Proven experience in management of change for organizational and technical initiatives

VP, Head of Engineering Center of Excellence

Miha Pongrac
Human Resources

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.

• Collection and preparation of documents intended for submission of CMC variation packages
• Evaluation of changes and support for their implementation in drug documentation for EU, US market, as well as monitoring the status of requests and agreed activities
• Participation in meetings for projects within responsibility and informing other organizational units about the content of the registration file
• Work with regulatory team and other functions to create solutions and implement agreed mitigation plans
• Provide regulatory input throughout the product life cycle of responsible product lines and understand or raise regulatory obstacles to Head of regulatory Function
• Preparation of responses to authorities’ requests within regulated timeframe
• Update status through electronic systems, database and relevant forums

• University degree (Pharmacist/Biologist/Chemist)
• 2-3 years of experience in regulatory affairs in CMC, quality assurance and control, drug development or analytics will be an advantage
• Experience of working with Multi-national companies in Pharmaceuticals
• Knowledge in regulation, requirements and guidelines
• Proficiency in written and spoken English languages
• Ability to work in dynamic environment and multi-tasking
• Ability to work both individually and in the team, to cooperate on cross-country level and with different business units
• Experience in global environment is an advantage
• Experience with sterile products is highly desirable
• Knowledge with electronic systems and databases

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.

• Prepare, publish and dispatch eCTD (CTD) lifecycle management submissions, ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance
• Archive published dossiers and administrative data according to the internal processes
• Accurately and timely updating internal working schedules, related to assigned task
• Troubleshoot submission and document issues
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions
• Develop and maintain working knowledge of internal and external publishing standards
• Work with the Manager to ensure completion of tasks within agreed timelines
• Other assignments as required

• Master's Degree (preferred in Life Sciences or Information Technology)
• Experience in the Pharmaceutical Industry in Regulatory Operations/Regulatory Affairs is a plus
• Experience in publishing regulatory submissions and using regulatory e-submission software is a plus (Veeva)
• Basic understanding of processes and departments within a pharmaceutical company is a plus
• Good knowledge of MS Office Suite and Adobe Acrobat
• Fluent English
• Ability to multi-task, pay close attention to detail, and follow projects through to completion
• Ability to work under pressure and to tight time deadlines
• Effective time and organisation management

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.

Thanks to a strategic focus on Cloud Migration, Digital Transformation, Cloud Native Computing, we have a great opportunity for anAssociate Director, Enterprise Architect, Cloud.

This is an opportunity for a technology expert who has an eye for detail, critical thinking, and problem-solving skills, who is willing to work collaboratively, and guide others as required. You will need to be proactive, resourceful, and able to work under pressure to meet challenging deadlines.

As an Associate Director, Enterprise Architect, Cloud you will be responsible for discovering and architecting IT platforms and solutions. Your responsibilities include the following:

• Develop and maintain the enterprise cloud architecture strategy, ensuring alignment with business goals and objectives.
• Assess current architecture (Cloud, On-Prem datacenters) and design new cloud architectures that meet the requirements and Teva’s strategy. Experience with designing solutions ranging from single system/landscape to large-scale data center migrations.
• Conduct regular assessments of cloud infrastructure and applications to identify areas for improvement and optimization.
• Lead efforts to transition from on-prem legacy architectures to cost effective cloud solutions, including reference architectures, guardrails, patterns.
• Communicate complex technical architectures and strategies to senior leadership and peers, ensuring alignment with enterprise architecture and business objectives.
• Lead the process of introducing new applications and technologies into the portfolio together with the ITMUs.
• Maintain major systems and technologies roadmaps. Plan with the ITMUs the implementation of this roadmap – in specific: major upgrades, technology changes and systems decommissioning.
• Ensure architecture meets security and compliance requirements for data privacy, compliance, and disaster recovery.
• Implement within the architecture, best practices including cost optimization, scalability, and performance.
• Responsible for identifying trends, disruptive applications and technologies that can substantially impact the ITMUs and business capabilities.
• Work closely with your architecture teammates, sharing information, collaborating, and supporting other architecture activities.
• Work closely with delivery teams such as: cloud engineering, infrastructure teams, security as well as other IT professionals to ensure that your solutions meet the requirements and can be integrated into existing IT landscape.
• Engage and support the ITMUs in performing Proof of Concepts of new applications and technologies.
• Keep up to date with new technologies and driving the evaluation and assessment of those technologies with various delivery units.
• Collaborate with business stakeholders and IT leaders to identify opportunities for digital, cloud-based solutions that can drive business growth and innovation.
• Lead and participate in digital innovation activities that may transform the way Teva works.

• A minimum of a bachelor's degree in a Computer Sciences or equivalent is required.
• A minimum of 5 years of Cloud architecture experience of Enterprise level platforms and projects in global companies.
• Proven knowledge and experience in the following domains: large-scale infrastructure deployments, hyperscalers (at least Azure and AWS), migration to cloud, cloud adoptions frameworks, virtualization (VMWare/Nutanix etc), data centers, network concepts (VPN, ExpressRoute etc) and backup solutions.
• Previous experience in designing the architecture of large platforms on public clouds (Azure/AWS/GCP) as well as modern and Cloud Native technologies
• Demonstrated ability to analyze business requirements and map to IT capabilities and platforms.
• Demonstrated ability to analyze systems requirements and design IT solutions, choosing the best fit for the architecture.
• A sustained record of success delivering complex IT Architecture and technology solutions to a diverse and global clientele.
• Able to drive innovation and continuous improvements for platforms and processes.
• Strong IT vendor management skills.
• Experience in working in a matrix managed organization (min 5 years)
• Up to date knowledge and experience with cyber threats and how to build architectures to mitigate cyber risks- advantage.
• TOGAF certificates – advantage.
• Experience working in a Pharma IT landscapes (GxP and non-GxP) – advantage.
• Project management capabilities
• Work in a dynamic environment with ever changing priorities.
• Stakeholder management – ensuring delivery and managing expectations.
• Planning and execution capabilities – seeing the process end to end.
• Good interpersonal skills, cordial and respectful.
• Excellent relationship-building skills, communication skills and team-based project experience.
• Able to engage and manage up, down and across the IT and business without formal authority.
• Able to develop and execute a vision for cloud based digital platforms and applications landscape.
• Fast and quick learner, with passion for technological innovations, able to self-educate and knowledge transfer.
• Team player – collaborating with others to achieve a greater goal.
• Excellent English written and verbal communication skills at a senior level both internally and externally.
• Travel Requirements: As needed by the business requirements.

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.