Regulatory Affairs Associate II
Kfar Saba, Israel, 0000000
Who we are
The opportunity
How you’ll spend your day
- 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
Your experience and qualifications
- 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
Make a difference with Teva Pharmaceuticals
Reports To
Assoc Dir Regulatory Affairs
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