Regulatory Affairs Coordinator

Your scope of work:

Regulatory Information & Management System RIMs:

• Manage Affiliate regulatory activities on relevant Roche systems : RIMs, SERT, GPRS-PID, 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 life-cycle maintenance/updating of registered products for any changes/updates other registration activities as required.
• Coordinate cross-functional 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 authorization,variations 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 fast-paced teams

• You have logical thinking and/or process analyst mentality

• You are fluent in English & French