Our client is a global pharma company located at the east side of Brussels.
This function is office based.
- To provide procedural, administrative and planning support for submissions
- To provide procedural, administrative and planning support for new submissions and variation submissions in the EU (including Norway and Iceland), Switzerland and the non-EU CES countries for products approved through the Centralized, Mutual Recognition and Decentralized procedures
- To provide administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements
- To plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission
- To draft module 1 components and to organize the gathering of the module 1 components
- To collaborate closely with Regulatory Operations to establish submission timelines and content of Module 1
- To collaborate closely with subsidiary Registration Managers in order to ensure timely submission
- To prepare the English Product Information (SmPC, label and leaflet) in collaboration with WPL
- For the centralized procedure: to supervise and coordinate the translation process to ensure timely submission to EMA
- To provide other administrative support related to Marketing Authorization Applications to Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed
- To ensure updates to regulatory databases
- To keep up to date with EU procedural requirements and legislation
- To participate as Subject Matter Expert in relevant work streams / projects as deemed appropriate by Regulatory Affairs Europe Senior Staff
- To lead regional submission cross-portfolio planning team meetings; agenda, decisions, action items
- To act as the regional point of contact (on status of regional regulatory milestones) for Business Owners
- Tto assist Business Owner in resolution of issues identified with acceleration or delay of regulatory milestones
- To interact as necessary with regional MMD planning and/or manufacturing sites regarding issues
- University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least two years of experience in the pharmaceutical industry with knowledge about regulatory affairs.
- Excellent written and verbal communication skills in English is a must; other European languages an asset
- Good understanding of the end-to-end pharmaceutical lifecycle
- At least 2 years experience in Regulatory Affairs