Senior Regulatory CMC Manager

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

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Education Level :


Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

Senior Regulatory CMC Manager

Salary :


Date Posted :

03 Sep, 2020

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Pharma Business Development Jobs

Experience :


Job Type:


Travel Amount:



Senior Regulatory CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

* Experience with drug and biopharmaceuticals, chemistry, biotechnology, analytics and pharmaceutical technology
* Knowledge of drug development process is advantageous
* Familiarity with evaluating data from a wide range of scientific disciplines
* Superb written and spoken communication plus negotiation skills along with a sense of effective planning as well as organizational and interpersonal skills
* Finished Degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or a in a similar field, an higher or advanced Degree in either one of these is a plus
* Languages: English, fluent in written and spoken,

Your tasks:

* Assisting with the implementation of global CMC submission activities like planning, authoring, reviewing, coordination and submission for assigned projects and products
* Leading, Managing and Formulating global CMC regulatory strategies focusing on innovation and maximizing the business benefit in balance with regulatory compliance
* Creating high quality strategic project documentations and presentations such as project plans, strategic documentation, lessons learned and more
* Preparing CMC responses to health authority question during the development, registration as well as product stages
* Working on first-class CMC documentation for HA submissions in regards of support and guidance, applying arranged CMC global regulatory strategies, assuring technical congruency and regulatory compliance while meeting agreed timelines and e-publishing requirements during the project lifecycle
* Analysing and identifying required documentation for world-wide submissions and negotiating the delivery of approved technical source documents in accordance with project timelines

* Establishing and maintaining good and deep working relationships with partners an customers

Basel, Switzerland

Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.

Going the Extra Mile.

As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.

Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

New to Switzerland? In case of a successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health- and social insurance
* Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

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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