Global Program Regulatory Manager

RM IT Services GmbH

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Job ID :

11660


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

Regulatory Affairs ,Compliance, Audit, Clinical Trials, CTA, health authorities,


Salary :

Negotiable


Date Posted :

31 May, 2018



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

upto 15%





Description

Global Program Regulatory Manager wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

* Excellent knowledge of regulatory submission and approval processes as well as portfolio brand management
* Proficiency in terms of product licenses, especially regarding preparation of documents for EU license renewals
* Expertise in HA negotiations as well as a solid understanding of post-marketing / brand optimization strategies and commercial awareness
* Languages: fluent English both written and spoken

Your tasks:

* Maintaining product licenses world-wide for assigned products as well as preparing IND/NDA Annual Reports and DSURs
* Operationally executing specific regulatory deliverables relating to world-wide maintenance, upkeep and lifecycle management of assigned global portfolio brands
* Preparing all necessary supporting documentation for EU license renewals, EU variations and PSUR submissions
* Addressing HA requests and leading preparation of HA responses
* Managing interactions with RA colleagues in CPOs and participating in regulatory subteams; preparation of IND/NDA Annual Reports & DSURs

Start: ASAP
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH12934

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

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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