דרושים United States, New York, Production Associate

• Collaborate with R&D Associates to determine/develop design-around formulations.
• Collaborate with outside counsel to determine/develop invalidity positions to relevant patents.
• Determine launch strategy, including labeling carve outs, and assess risk associated with launch.
• Manage European Patent Office Oppositions and similar actions in national patent offices.
• Manage Unified Patent Court revocations.
• Collaborate with colleagues in other teams to ensure all global issues are addressed, including manufacturing site, device, and API issues.
• Collaborate with Regulatory Affairs Associates to support regulatory submissions.
• Collaborate with Portfolio Team to support identification of potential generic products for Teva’s European and International markets including providing IP landscapes and IP launch scenarios.
• Collaborate with Business Development to determine launch strategy, including labeling carve outs, and assess risk associated with launch for in-licensed generic products.
• Collaborate with Medis to support Medis’ out-licensing of Teva’s generic products.
• Manage outside opinion counsel to ensure high quality work product on time and within budget.

• Collaborate with R&D Associates to determine/develop design-around formulations.
• Collaborate with outside counsel to determine/develop invalidity positions to relevant patents.
• Determine launch strategy, including labeling carve outs, and assess risk associated with launch.
• Manage European Patent Office Oppositions and similar actions in national patent offices.
• Manage Unified Patent Court revocations.
• Collaborate with colleagues in other teams to ensure all global issues are addressed, including manufacturing site, device, and API issues.
• Collaborate with Regulatory Affairs Associates to support regulatory submissions.
• Collaborate with Portfolio Team to support identification of potential generic products for Teva’s European and International markets including providing IP landscapes and IP launch scenarios.
• Collaborate with Business Development to determine launch strategy, including labeling carve outs, and assess risk associated with launch for in-licensed generic products.
• Collaborate with Medis to support Medis’ out-licensing of Teva’s generic products.
• Manage outside opinion counsel to ensure high quality work product on time and within budget.

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, IL 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/ Engeneering/ Biomedical)
• 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 and Hebrew
• Ability to work in dynamic environment, 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- advantage
• Experience with sterile products
• Experience with medical device combined product- advantage
• Knowledge with electronic systems and databases

Assoc Dir Regulatory Affairs

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.

• Preparation of timely and accurate quarterly financial statements according to US GAAP
• Manage the yearly statutory financial statements and tax returns preparation and submission
• Perform accounting and audit procedures in collaboration with Teva's external auditors
• Ensure reporting processes are in line with SOX and Teva's compliance policy
• Perform monthly balance sheet reconciliations and review of accounts, to ensure all financial transactions are properly reflected in the General Ledger
• Providing accounting support to business units and corporate functions, as part of the period end close activities, and in accordance with regulatory requirements and corporate policies
• Supervise work performed by Israel Accounting team members

• Academic degree in Accounting. CPA – must
• 3+ years of relevant work experience
• Experience in employee management and development
• Big 4 audit experience – an advantage
• Previous experience with US GAAP reporting standards and Israeli tax filing requirements - an advantage
• Excellent ability to work independently and proactively
• Experience working with Oracle, SAP or similar ERP system – an advantage
• Excellent written and verbal communication skills
• Team player with good interpersonal skills
• Strong English skills, written and verbal
• Ability to work under pressure

Sr Dir Accounting Israel

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.