Associate Regulatory Site Officer

at  Kono Consultants

VACANCY:

For Regulatory Site Officer (RSO) team support, we are urgently looking for a knowledgeable candidate to be able to support on regulatory CMC dossier management activities for several pharmaceutical products in our portfolio. Due to some extended scope activities for our products (additional new market registrations and major variations), additional workforce is required to support in Q3 and Q4 2024.

SKILLS/REQUIREMENTS

• Bachelor or master with scientific background
• CMC background/experience required
• Regulatory background/experience required + experience with major market submissions such as US, EU, Japan, China,…
• Regulatory database (Veeva Vault RIM) experience required
• Good organizational skills
• Attention to details
• Good communicator and project manager

• Managing and reviewing of CMC (Chemistry, Manufacturing and Controls) dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibility
• Implementing change control updates from our partnered sites into the existing regulatory dossiers and prepare associated regulatory CMC documentation for submission to the authorities, in collaboration with experts and external partners
• Analyzing impact of proposed change controls on the existing regulatory submissions
• Review operational documentation/reports in order to ensure compliance with the dossiers