commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications – non-small cell lung cancer, pancreatic cancer, and other types of solid cancers.
Support in the preparation and management of documentation for global regulatory submissions in a timely manner.
Support in the preparation of responses to regulatory queries from global regulatory authorities.
Organization and maintenance of records and correspondence with all parties involved in the regulatory document control center.
Maintain processes and monitor practices to ensure regulatory compliance.
Research regulatory issues and provide guidance and advice to colleagues.
Assist in the research and dissemination of global regulatory intelligence topics.
Liaise with cross functional teams such as engineering, QA, supply chain, pre-clinical and clinical development on projects
QUALIFICATIONS/KNOWLEDGE:
Qualifications:
MSc degree in life sciences
Knowledge:
5+ years of experience in regulatory affairs and/or QA within the Medical device/ pharmaceutical industry.
Knowledge of international regulations for the EU, US, Japan, China and others
Knowledge of the ISO 13485
Experience in writing procedures and regulatory documents
Fluent in English, both written and spoken, and other European languages is an advantage
Ability to work consistently and effectively as part of a team
Attention to detail
Ability to work under pressure to meet aggressive deadlines
Critical thinking, reasoning, and problem-solving capability
Excellent Office software proficiency
