Regulatory CMC Associate Manager

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Master of Science

Address 1 :

Western Europe,--Basel,Basel,

Key Skills :


Salary :


Date Posted :

31 Jan, 2018

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Pharma Manufacturing Jobs

Experience :


Job Type:


Travel Amount:

upto 15%


Regulatory CMC Associate 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, advanced degree is desirable
* Working expertise in chemistry, biotechnology or pharmaceutical technology
* Knowledge of Regulatory Affairs and reasonable approach to risk assessment is a must
* Know-how in drug development process, regulations, guidelines for NCEs and product life cycle maintenance is desirable
* Competency of cooperating with multinational project teams and coordinating multiple projects simultaneously
* Languages: fluent English both written and spoken, desirably good spoken German skills

Your tasks:

* Preparing high-quality CMC documentation for Health Authority (HA) submission applying agreed CMC global regulatory strategies and assuring technical congruency as well as regulatory compliance
* Providing CMC responses to health authority questions during development, registration and product lifecycle
* Identifying required documentation for global submissions as well as content, quality and timeliness issues with source documents
* Keeping knowledge up to date with regard to regulatory guidelines, requirements and new technical trends in all global regions
* Contributing to the regulatory strategy, identifying the critical and establishing sound working relationships with partners and customers
* Supporting the general department regarding DRAGON (Drug Reg Affairs Global Regulatory Compliance System) annual and product renewal writing

Start: ASAP
Duration: 11MM+
Location: Basel, Switzerland
Ref.Nr.: BH12324

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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