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Job Details

Global Regulatory Manager

Company: RM IT Professional Resources AG
Location: Basel
Reference: BBBH12426
Closing Date: 22 Feb 18
Type: Contract
Salary (£): Negotiable

Job Summary:

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


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

Your experience/skills:

* BSc or MSc with requisite experience and demonstrated capability, preferably degree as MD, PhD or PharmD
* 2-4 years professionalism in regulatory and drug/biologic development spanning activities in Phases I-IV
* Experience with regulatory submission and approval processes in one or more major regions in addition with familiarity within a global or matrix environment and cross-functional teams in the pharmaceutical industry
* Ability to understand of post-marketing and brand optimization strategies and commercial awareness preferred
* Confidence in HA negotiations
* Languages: fluent English both written and spoken

Your tasks:

* Implementing a global regulatory strategy for timely submissions and approval with the best possible label based on available data as well as integrating the global strategy into regional submissions worldwide
* Specifying requirements and setting objectives for Health Authority (HA) interactions with GPRD
* Collaborating with HAs as appropriate in meetings with GPRD as well as coordinating and planning rehearsals for HA meetings
* Submitting Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
* Identifying issues, gaps, and tradeoffs affecting optimal and timely submission and approval
* Organizing and preparing submission of dossiers in assigned regions worldwide along with reviewing of global dossier summary documents

Start: 03/2018
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH12426

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

Apply for this job: Global Regulatory Manager

Contact Information:

Address:  Head Office
Foerrlibuckstrasse 10, 8005 Zurich

Website:  Visit Our Web Site

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