Regulatory Affairs Coordinator 12 months contract
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Job Description
Roche fosters diversity equity and inclusion representing the communities we serve. When dealing with healthcare on a global scale diversity is an essential ingredient to success. We believe that inclusion is key to understanding peoples varied healthcare needs. Together we embrace individuality and share a passion for exceptional care. Join Roche where every voice matters.
The Position
Your scope of work:
Regulatory Information & Management System RIMs:
Manage Affiliate regulatory activities on relevant Roche systems : RIMs SERT GPRSPID IP CRDB.
Ensure RIM system compliance with regards to dates tracking archival and content management.
Manage product information updates with respect to Roche and local regulatory requirements and for Roche databases
Ensure that complete records/files of all product dossiers and updates submitted and approved by the regulatory authorities are maintained and archived properly on RIM and internal databases.
Other :
Support on lifecycle maintenance/updating of registered products for any changes/updates other registration activities as required.
Coordinate crossfunctional collaboration with Marketing associates on promotional material submission processes.
Serve as a key liaison between Regulatory partners Marketing Associates and Finance departments to facilitate smooth regulatory interactions.
Any other duties that may be assigned from time to time as required by the business.
Ensure timely preparation submission of regulatory dossiers and related documentations: New Marketing authorizationvariations and renewals to the local HA.
Who you are:
You have a Degree in Pharmacy
Your have Knowledge in pharmaceutical regulations and local requirements
You have tenacious attention to detail and consistency especially with respect to data style format and layout and ability to format technical documents using electronic tools
You have the skills for collaboration and the ability to interface effectively with colleagues
You have ability to work in fastpaced teams
You have logical thinking and/or process analyst mentality
You are fluent in English & French
Who we are
At Roche more than 100000 people across 100 countries are pushing back the frontiers of healthcare. Working together weve become one of the worlds leading researchfocused healthcare groups. Our success is built on innovation curiosity and diversity.
Roche is an Equal Opportunity Employer.
Required Experience:
IC
Employment Type
Full-Time
