Support in Regulatory Affairs in EU, UK, Switzerland and the non-EU Balkan countries Reference number: 2238

Job description

Support RA activities in the EU, UK, Switzerland and the non-EU Balkan countries for products approved through the centralized and decentralized/MRP procedures – in collaboration with the Regulatory Liaison.

What you'll do

• Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements
• Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
• Drafts of module 1 components and organizing the gathering of the module 1 components.
• Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
• Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
• For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
• Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
• Ensures updates to regulatory databases.

Profile

• University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
• Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.