Beschreibung
We have a new opportunity for experienced Regulatory Affairs Manager to focus on regulatory affairs projects in early development.Responsibilities:
to provide input into global regulatory strategy for early development compounds.
contribute to regulatory innovations (e.g. novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways).
contribute to identification of regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approval.
be a key contributor in the core project Teams to the overall project development strategy.
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.
Requirements:
Degree - 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. Strong experience in regulatory affairs 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, 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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.