The early development regulatory manager will contribute to bring innovative novel therapies to patients as quickly as possible. The regulatory manager will play a critical role in defining the optimal regulatory strategy for first in human (FIH) and proof of concept (POC) studies and contribute to the long-term strategy of the projects to registration in collaboration with RA colleagues in Global Drug Development (GDD). Join us at the scientific frontier!
Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (immediately until 14.03.2022) we are looking for a
Regulatory Manager (m/f/d), 100%
- 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 nice-to-have in this role. Advanced degree (MD, PhD, PharmD) is a plus
- 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.
- Fluent English (oral and written) as a business language.
… please contact Mr. Renato Imboden by phone on 061 269 90 60