Global Program Regulatory Manager, Early Development, Oncology

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Master of Science

Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

Regulatory Affairs, CMC, CTAs, INDs, Early Clinical Development

Salary :


Date Posted :

31 Jul, 2019

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



My client, a well renowned pharmaceutical 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 high unmet 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).


* You will be responsible to provide input into global regulatory strategy for early development compounds.
* You will 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 and approval.
* 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, problem solving skills and capacity to work in a global/matrix environment.

If this may be of interest and you feel this would suit your experience please apply and feel free to get in touch with Ross Wilson at to discuss further

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

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