Regulatory Affairs CMC Manager

RM IT Services GmbH

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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 :

29 Jun, 2018

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:

upto 15%


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

Your experience/skills:

* Degree in Science, e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, or equivalent
* 2+ years' work experience in regulatory affairs preferred as well as working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
* Demonstrated track record of successful work in interdisciplinary teams, planning, coordinating and executing activities simultaneously on multiple projects
* Ability to critically evaluate data from a broad range of scientific disciplines and a reasonable approach to risk assessment
* Expertise in regulations, guidelines for NCEs and product life cycle maintenance

* Languages: fluent English both written and spoken, well-spoken German desired

Your tasks:

* Determining and leading global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
* Communicating CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and respective departments
* Implementing all global CMC submission for assigned projects, while applying the global strategy into submissions
* Authoring high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance
* Maintaining a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products
* Initiate and leading Health Authority interactions and negotiations as appropriate as well as driving cross-functional CMC Health Authority Response Teams (HARTs) for as-signed development

Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13074

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.

For more information,visit

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