Job Reference: 23745
Job Duration: 6 months
Start date: ASAP
Description:
My client, a well renownedpharmaceutical company based in Basel, is looking for a Global Program Regulatory Manager, Early Development, Oncology on a 6 month contract basis. You will work in close coordination with scientists of NIBR on innovative medicines in diseases with a highunmet medical need that are centered on NIBRs scientific discoveries.
The regulatory manager will perform a vital 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).
Responsibilities:
* You will be responsible to provide input into global regulatory strategy for early development compounds.
* Youwill contribute to regulatory innovations (e.g. ovel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways).
* You will work to identify regulatory issues, gaps, and tradeoffs affecting optimal and timely submission andapproval.
* You will be an important contributor in the core project Teams to the overall project development strategy.
* You will be part of 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 take part in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs.
Ideal Candidate:* A Science based BS or MS with requisite experience and proven 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 exposure, including activities in early development and Phase I-IV, ideally 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, problemsolving skills and capacity to work in a global/matrix environment.
If this may be of interest and you feel this would suityour experience please apply and feel free to get in touch with Ross Wilson at rwilson@keypeople.co.uk to discuss further
Industry: Pharmaceuticals
Salary:
Salary Benefits:
Vacancy Type: Contract
Job Skills: Regulatory Affairs, CMC, CTAs, INDs, Early Clinical Development
Contact Name: Ross Wilson
Website: -
Direct Application URL: -