For one of our clients we are looking for a Global Program Regulatory Manager (GPRM), Early Development, Oncology.
- Do you have a Science based BS or MS with requisite experience and demonstrated capability ?
- Do you have a 2-4 years of regulatory experience, spanning activities in early development and Phase I-IV ?
- Do you have a scientific knowledge and any additional drug development experience in discovery research ?
The you might be the candidate we are looking for! Don't hesitate to apply now!
The client’s Institutes for Biomedical Sciences is world-renowned for its groundbreaking science in drug development including cell and gene therapy. You will work closely with scientists of the client on innovative medicines in diseases with a high unmet medical need that are based on scientific discoveries. 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!
- 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, 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.
+32 15 21 11 04
Start date – 2nd September 2019
LOA – 6 Months
Availability - Full time onsite 4 – 5 Days per week