Global Program Regulatory Affairs Manager Oncology

RM IT Services GmbH

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Job ID :

15182


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

Regulatory Affairs, Oncology, early development,


Salary :

market rate


Date Posted :

09 Aug, 2019



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Global Program Regulatory Affairs Manager (Oncology) vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

* A Science based BS or MS. Advanced degree (MD, Ph D, PharmD) is a plus. Fluent English.
* 2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably focus on EU regulatory affairs.
* Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology etc.

Your tasks

* 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 aTeam 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 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.



Start: 09/2019
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH14677

Did this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number.

As a preferred recruitment agency for Swiss banks, international insurance, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern and other regions in Switzerland every day.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile…

New to Switzerland? In case of successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health - and social insurance
* Work permit and much more


Company Name:

RM IT Services GmbH


Headquarters:

Hackescher Markt 2-3,


Sector:

Staffing Firms


Country:

Germany


Zipcode:

10178


Website:

www.rmgroup.ch


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


Phone No. :

+41583560693


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

For more information,visit www.rmgroup.ch.

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