job details

posted: 27. June 2018
location: aubonne, geneva
sector: Life Sciences
job type: temporary
reference number: 11332
contact: clémentine dupuis, geneva professionals health care & life sciences
phone: 058 201 54 40

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job description

Urgent role

One of our Global pharmaceutical client is looking for a Regulatory CMC Dossier Expert or RA Affairs, technical Writer.

Your responsibilities are:

Lead and drive CMC regulatory activities (writing, approval,..)
Lead the dossier content and interaction with CMC technical functions for concerned molecules of specific focus area
Provide support during Health Authority interactions on CMC registration
Responsible for translation and interpretation of the country regulatory requirements into CMC/Technical requirements
Secure CMC Regulatory Compliance for the products
Responsible for the creation of the quality reference files for products under own responsibility
Module II and module 2.3

Qualification:

At least 3 to 4 years of successful of scientific writing, with CMC regulatory experience
Sense of urgency, must have the drive/motivation to take action
Experience module 2 and 2.3 writing
Excellent English (written and oral)

If your profile corresponds closely, please do not hesitate to send us your CV, latest certificates and the date of your availability. Only online applications will be considered. We look forward to your application.

A valid Swiss work permit OR Swiss or EU-25/EFTA citizenship is required.

cmc - regulatory affairs - writing modules 2 and 2.3 in Aubonne

job description

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