Senior Regulatory CMC Manager

RM IT Services GmbH

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Job ID :

16809


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,Switzerland,Switzerland,


Key Skills :

Regulatory, CMC


Salary :

Negotiable


Date Posted :

14 Apr, 2022



Company Name :

RM IT Services GmbH


Location1 :

Switzerland




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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

Your tasks:

* Creating high-quality CMC documentation for HA submission as well as applying agreed CMC global regulatory strategies
* Preparing CMC responses to health authority questions during development, registration and product lifecycle
* Determining the required documentation for global submissions and negotiating the delivery of approved technical source documents
* Identifying issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
* Performing activities in support of the general department such as annual and product renewal writing, coordination of source documentation and other database entry activities
* Establishing and maintaining sound working relationships with partners and customers

Your experience/knowledge:

* Knowledge of chemistry, biotechnology, analytics or pharmaceutical technology
* Well-versed with critically evaluating data from a broad range of scientific disciplines
* Regulatory experience or expertise in drug or biopharmaceuticals is desirable
* Knowhow of regulations, guidelines for NCEs and product life cycle maintenance is a plus
* Degree in Science like Chemistry, Pharmacy, Biochemistry or Biology or equivalent
* English, fluent in written and spoken

Your soft skills:

* Excellent planning and communication skills along with a reasonable approach to risk assessment
* Ability to work with extended project teams and coordinate activities simultaneously on multiple projects

Location: Basel, Switzerland
Sector: Pharmaceuticals
Start: 05/2022
Duration: 8 months with an option for extension
Ref.Nr.: BH18589

Take the next step and send us your CV and contact phone number on which we can reach you during working hours.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are welcome, we will support you all the way.
By applying, you agree to the storage and processing of your data for the application process. We strictly comply with the applicable data protection laws.


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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