Global Program Regulatory Manager, Early Development, Oncology

Key People


Job ID :

15162


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

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


Salary :

Negotiable


Date Posted :

31 Jul, 2019



Company Name :

Key People


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

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).

Responsibilities:

* 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 rwilson@keypeople.co.uk to discuss further


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

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.

For more information,visit www.keypeople.co.uk.

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