Regulatory CMC Manager

RM IT Services GmbH

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Job ID :

9225


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,Switzerland,Stein,


Key Skills :

Regulatory Manager


Salary :

Negotiable


Date Posted :

23 Oct, 2017



Company Name :

RM IT Services GmbH


Location1 :

Stein




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

100.00%





Description

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

Your experience/skills:

* University degree in relevant field
* At least 5 years' of professionalism in RegCMC with extensive production knowledge
* Ability to identify needs and contribute in cross-site initiatives as applicable within and beyond the site context to improve and elaborate processes e.g. addressing gaps and/or achieving improvements in change control process
* A Profound background in the pharmaceutical sector would be beneficial
* Languages: fluent English and German both written and spoken

Your tasks:

* Collaborating with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
* Coaching, training and developing the site's personnel on regulatory specific aspects of change management and regulatory intelligence information
* Facilitating timely provision of good quality source documentation, involving co-authoring as applicable and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices
* Ensuring on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products
* Addressing and resolving issues related to regulatory compliance checks, maintaining an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities

Start: ASAP
Duration: 8MM+
Location: Basel, Switzerland
Ref.Nr.: BH11701

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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