Regulatory CMC Manager

RM IT Services GmbH

Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Bachelor of Business Administration,Master of Businees(MBA),Master of Science

Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

cGMP, GMP, GxP, RegCMC, Regulatory Affairs,

Salary :


Date Posted :

06 Jun, 2018

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:

upto 15%


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

Your experience/skills:

* University degree in a relevant field
* 5+ years' working experience as Regulatory CMC Manager along with production background
* Domain knowledge in the pharmaceutical sector is an advantage
* Languages: fluent English and German both written and spoken

Your tasks:

* Operating as single point of contact and advisor for worldwide regulatory intelligence information on the site
* Coaching the site's personnel on regulatory aspects of change management for handling change requests and maintaining regulatory compliance as well as supporting the site in setting standards for regulatory relevant information included in CMC modules
* Providing support for the site in generation of change control strategies as well as verifying regulatory relevance of changes and guiding regulatory strategic as member of change control board
* Supporting the CMC documentation preparation by provisioning good quality source documentation, including comments from technical experts to CMC of Regulatory Affairs while ensuring regulatory compliance, quality oversight and adherence to best practices
* Ensuring on-site coordination, support and guidance for the preparation of CMC responses to Health Authority requests for site specific products
* Disclosing issues regarding regulatory compliance checks and maintaining an oversight of any compliance remediation activities at the site

Start: ASAP
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH12970

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


Hackescher Markt 2-3,


Staffing Firms







100 - 499


Pharmaceutical Recruitment

Phone No. :


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.

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