Global Program Regulatory Manager (GPRM)

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Bachelor of Business Administration,Master of Businees(MBA)

Address 1 :

Western Europe,Switzerland,Basel-Country,

Key Skills :

Global Program Regulatory Manager (GPRM)

Salary :

Market Rates

Date Posted :

17 May, 2021

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



Global Program Regulatory Manager (GPRM) vacancy for our Basel based client in the pharmaceutical sector.
Your experience/skills:

* 2+ 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
* 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 and problem solving skills with the ability to work in a global matrix environment
* A science based Bachelor or Master with requisite experience and demonstrated capability, an advanced degree such as MD, Ph D, PharmD is a plus
* Languages: English, fluent in written and spoken

Your tasks:

* Providing input into global regulatory strategy for early development compound
* Contributing to regulatory innovations such as novel therapeutic approaches, indications, endpoints or any innovative regulatory pathways
* Identifying regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approval
* Working in a high-performing multi-disciplinary team to ensure submission of clinical trial applications and investigational new drugs along with related maintenance activities such as amendments, annual safety reporting, investigator brochures, end of trial notifications and submission of CSR
* Assisting in the core project teams as a key contributor to the overall project development strategy
* Participating in regulatory activities, in planning early health authority interactions and in negotiations with health authorities to address queries on INDs and CTAs

Start: 06/2021
Duration: 10MM+
Location: Basel, Switzerland
Ref.Nr.: BH17012
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

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

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Company Name:

RM IT Services GmbH


Hackescher Markt 2-3,


Staffing Firms







100 - 499


Pharmaceutical Recruitment

Phone No. :


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.

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