An excellent opportunity has arisen for an experienced Regulatory Consultant to join a global pharmaceutical company on an initial 6 month contract basis based in Basel, Switzerland. Within this role you will play an important part in defining regulatory strategy for first in human (FIH) and proof of concept (POC) studies and contribute to the long-term strategy of the projects.
*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 a high-performing multi-disciplinary Team 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, end of trial notifications, submission of CSR 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.
*A Science based BS or MS with requisite experience and demonstrated capability. Scientific curiosity is a must in this role. Advanced degree (MD, Ph D, PharmD) is a plus. Fluent English (oral and written) as a business language.
*2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU regulatory affairs. Additional knowledge of other regions is an asset.
*Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline, as well as with biologics is an asset.
*Strong interpersonal, communication, negotiation, problem solving skills and ability to work in a global/matrix environment.
For further information, please contact Tim Barratt on +44(0)1727 817626 or email firstname.lastname@example.org