CMC Manager

RM IT Services GmbH

Sorry, This job post has expired.

Job ID :

15256


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

CMC, Regulatory affairs, HA submissions, pharmaceutical,


Salary :

market rate


Date Posted :

29 Aug, 2019



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

CMC Manager vacancy requiring profound Regulatory(CMC) knowledge for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

* Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
* Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
* Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
* Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Your tasks:

* Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and reg-ulatory compliance
* 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 po-tential authoring issues that may impact submission quality or timelines, as early as pos-sible.
* Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.

Start: ASAP
Duration: 9MM+
Location: Basel, Switzerland
Ref.Nr.: BH14794

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.

View all RM IT Services GmbH Jobs



© 2019 Jobsinpharma - 4ward Technologies Ltd All rights reserved.