Job Title: Senior Regulatory Affairs Officer New
A highly skilled position for a Senior Regulatory Affairs Officer is now available in the pharmaceutical industry. This role involves managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, writing local modules and administrative documents, compiling regulatory documentation, and communicating with European Regulatory Authorities.
About the Job:
* Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical products.
* Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers.
* Write the local modules (ex: module 1) and administrative documents.
* Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP and national applications in line with assigned timelines (including responses to questions).
* Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed. Follow-up of the submissions with HA.
Requirements:
* LIFE SCIENCE QUALIFICATION
* 2-3 years in experience in Regulatory Affairs, in particular good knowledge of EU procedures (DCP, MRP)
* Ability to multi-task
* Ability to communicate with colleagues in global countries
* Autonomy, multi-tasking abilities