Lead Regulatory Affairs Professional jobs at Teva in Croatia, Zagreb

• Technical/functional knowledge in Accounting and reporting process area
• Ensuring that accruals are properly recorded and analyzed
• Preparation of Journal Entries & Supporting schedule
• Supporting monthly and quarterly activities of multiple entities
• Analysis of the various accounts and variances per legal entities, obtain explanation on deviations and prepare a summarized reporting on a monthly basis within scheduled time
• Preparation and review of account reconciliations
• Overall understanding of how processes within Financial Reporting area influences system feeds and final reports
• Supporting standardization of processes and tasks across the team
• Acting as a key contact for local and global teams for record-to-report related questions
• Ensuring that accounting books and records comply with accounting policies and regulations
• Providing supporting documents and explanations for all internal and external audits as and when required
• Participating in ad-hoc projects

• University education in Accounting or Finance required
• Minimum 3 years of experience in accounting and/or auditing
• Preferably familiar with US GAAP
• Good knowledge of Sarbanes Oxley Act and/or internal control concepts
• Good working knowledge of SAP or any other ERPs
• Good understanding of accounting and reporting processes
• Good analytical skills
• Fluent verbal and written communication in English, other language is a plus
• Experience in a multinational firm or within a shared service center is preferred
• Hands-on and proactive; strong organizational skills
• Accustomed to working with deadlines, in a dynamic environment
• Results driven and service-oriented to internal and external customers
• Excellent collaboration with colleagues within the local organization and with the colleagues of the global business service to support the overall Finance department’s goals and objectives
• Flexible and able to work in a changing environment
• Strong focus on improvement opportunities
• Want to work in a new established team

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.

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.

IT Management Operations (ITMO) is the central organization for managing IT operations, providing a comprehensive cross-IT perspective to enhance decision-making, ensure strategic alignment, and deliver quality and operational excellence across Global IT.

This role can be based in Croatia or India.

• Support annual IT cadences for selected IT management units (ITMUs) such as developing the Long-Range Plan, Annual Operating Plan, Capex Management, Project Portfolio Management, Strategic Information Systems Plan, applications and projects approvals, as well as overall projects portfolio status tracking and reporting to CIO & Management
• Work closely with the IT Management unit (ITMU) Lead, ITMU leadership, project managers, and support functions such as Finance, Architects, Infrastructure, Security and others
• Ensure alignment with overall IT and Teva strategy, drive Global IT processes within the ITMU, and serve as an extension of the ITMU lead, ensuring timely decisions, prioritization of activities, successful delivery of IT projects, and operational efficiency
• Standardize processes across IT to drive effectiveness and efficiency, ensuring clear visibility to IT leadership and the CIO on the status of IT activities
• Gain wide cross-IT visibility and impact by collaborating with various IT units and engaging with the IT leadership team to drive strategic initiatives and improvements

• Bachelor's degree in information technology, Business Administration, or a related field
• Extensive experience in managing relationships with senior stakeholders
• Experience as IT Project Manager or IT PMO
• Proven track record in a senior IT role, with a focus on global scale applications and project portfolio management
• Strong understanding of IT ways of working, strategic planning, and organizational change management
• Familiarity with industry standards and regulatory requirements such as ITIL, GxP, SOX, and others
• Experience in a headquarters role within a large organization is an advantage

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 dealmaking execution and strategy for driving Teva’s growth in innovative medicines on a global scale and scope. Significant focus on near-term opportunities to enhance our commercial business.
• Identify, evaluate, structure, negotiate and close a diverse range of transactions, including in-licensing, out-licensing, co-development partnerships, joint ventures, funding agreements and M&A / Bolt-On opportunities.
• Leads as the internal champion to drive alignment and gain endorsement for the proposed transactions, collaborations, and partnerships. Collaborate with cross functional teams, including R&D, legal, finance and commercial, to assess opportunities and ensure alignment with corporate goals.
• Oversees all internal “deal teams” to drive internal and external processes to bring deals to closure. Foster a culture of accountability, continuous improvement and cross-functional collaboration. Assess, build, mentor and lead a high-performing team across multiple locations.
• Rigorously manage KPI’s for evaluation and transaction execution timelines. Holding themselves and team accountable for progress against milestones.
• Serve as a key ambassador and spokesperson for Teva’s Innovative business development aims and objectives with innovative global biopharma companies and biotech companies. Represent the company at industry conferences, networking events and in negotiations with potential partners.

• Proven Track Record in Transactions Demonstrated success in sourcing, evaluating, structuring, negotiating, and closing complex deals, including BD&L, M&A, strategic partnerships, and financing transactions within the pharmaceutical or biotechnology sectors.
• Strategic Leadership Enterprise-level experience shaping business development strategy and driving execution in a fast-paced, competitive, and highly matrixed global organization.
• Industry Expertise Deep familiarity with the pharma/biotech ecosystem, preferably gained through a senior leadership role in a global big pharma or large biotech organization.
• Global Collaboration Ability to influence and engage senior stakeholders across diverse functions and international geographies, fostering alignment and cross-functional collaboration.
• Agility in Ambiguity Proven ability to operate effectively in environments of uncertainty and change, demonstrating resilience, resourcefulness, and swift decision-making.
• Operational Execution Hands-on experience leading lean teams and delivering results in complex, high-stakes environments through a mix of pragmatism, creativity, and accountability.
• Executive Partnership Trusted advisor and thought partner to senior executives, including EVP-level leaders, contributing strategic input and business development insights at the highest level.
• Industry Presence & Network Recognized industry reputation and an extensive network that enables access to high-value opportunities and key decision-makers.

Attributes:

• Educational Background Advanced degree in a relevant field (e.g., MBA, PhD, JD, or equivalent experience) preferred.

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.