Global Program Regulatory Affairs Manager (Oncology) vacancy for a globally operating Basel based company in the pharmaceutical sector.
* A Science based BS or MS. Advanced degree (MD, Ph D, PharmD) is a plus. Fluent English.
* 2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably focus on EU regulatory affairs.
* Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology etc.
* You will be responsible to provide input into global regulatory strategy for early development compounds.
* You will contribute to regulatory innovations (e.g. novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways).
* You will contribute to identification of regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approval.
* You will be a key contributor in the core project Teams to the overall project development strategy.
* You will work in aTeam to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator Brochures etc.
* You will participate in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs.
Location: Basel, Switzerland
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