Manager Regulatory Affairs (f/m) Job in Aesch, Switzerland

We are a dynamic and innovative group of companies dedicated to pharma­ceutical industry services focusing on the development, registration and manufacturing of generic and innovative medications based on sophisticated formula technologies, for which we possess in-house patents as well.

In the course of the growth and development of our market position we would like to further reinforce our team. We are therefore looking for an initiative and motivated

Manager Regulatory Affairs (f/m) Job Description

In this challenging position you will assume responsibility for the regulatory support of our development projects and marketed products for all regulatory topics with a major focus on submission and registration in Switzerland and European Union.

The major tasks included in this important role are

• Provide strategic regulatory input and guidance to project teams concerning reg­istration procedures and international registration dossier requirements
• Manage Health Authority interactions (main focus swissmedic), e.g. scientific advices, pre-submission meetings and proactive management of approval pro­cedures and maintenance / LCM (life cycle management) activities
• Prepare and / or coordinate regulatory submissions, such as scientific advice requests and briefing documents, IMPDs/INDs, MAAs/ANDAs, response docu­ments and variation packages
• Review and / or writing of Module 1, 2 and 3 documents as well as review of Module 4 and 5 documents
• Liaise with all relevant internal departments and partner companies to ensure availability of required documentation
• Act as interface to consultants for all regulatory work performed externally
• Evaluate proposed and planned CMC changes for approval relevance
• Ensure that necessary variations are created in good quality and on time so that all conditions of a rapid regulatory approval are given
• Maintain master dossier for assigned products for international registrations in other regions and support Regulatory Country Managers with all necessary product specific regulatory CMC documentation and know-how
• Maintain a registration status database to have a complete and accurate over­view about the approval status of all assigned products and regions
• Perform dossier due diligences for in licensing products

Manager Regulatory Affairs (f/m) Job Requirements

The minimum educational requirements for this demanding position are a Masters Degree in Pharmacy, Chemistry, Biology or another life science. Furthermore sev­eral years of industry experience is key, preferable in Swiss/European regulatory affairs. You also have a good understanding of the drug development or production process as well as knowledge of various international regulatory requirements and the registration procedures.

Other prerequisites for this position are excellent analytical, planning and organisa­tional skills and an independent working style. Additionally, you have good commu­nication, negotiation and interpersonal capabilities which enable you to successfully influence others in a matrix organisation and to build effective relationship with Health Authorities.

You fluently read, write and negotiate in English and German language, further lan­guages are of advantage. Computer literacy (MS-office tools) is a must, good un­derstanding of databases as well as eCTD / Document Management Systems an asset.

You are a target-oriented personality and able to work under pressure and on multi­ple tasks simultaneously.

If you are interested in working for a company that offers such challenging opportu­nities, we invite you to send your application along with all pertinent documents - preferably via e-mail into one PDF document - to Mr. Boris Brändli.
 

Manager Regulatory Affairs (f/m) Application Information

Please apply with your CV and cover letter by the 'apply' button below

Remember - you found this opportunity on Qreer.com

Manager Regulatory Affairs (f/m) Summary

Apply