Regulatory Affairs Associate II

10 hours ago

Israel Teva Full time ₪40,000 - ₪80,000 per year

Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. 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
Reports To

Assoc Dir Regulatory Affairs

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