Regulatory Affairs CMC Associate Manager

RM IT Services GmbH

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Job ID :

15186


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

Regulatory affairs, CMC, pharmaceutical


Salary :

market rate


Date Posted :

12 Aug, 2019



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Associate Manage Regulatory Affairs CMC vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:
* Minimum 2 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
* Working knowledge of chemistry/biotechnology, analytics or pharma-ceutical technology. Knowledge of the drug development process desirable.
* Knowledge/experience of regulations, guidelines for NCEs and prod-uct life cycle maintenance desirable.
* Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.

.Your tasks:

* Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies.
* Prepare CMC responses to health authority questions during development, registration and product lifecycle.
* Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
* Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
* Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.

Start: 09/2019
Duration: 04MM+
Location: Basel, Switzerland
Ref.Nr.: BH14669

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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