Job Description
European Regulatory Procedural Strategist
About the Job
As a European Regulatory Procedural Strategist, you will be responsible for managing the operational and procedural aspects of European regulatory filings within the Centralised Procedure. You will work closely with the European Regulatory Liaison group and regional/global functions to ensure timely preparation and filing of Marketing Authorisation Applications and Life Cycle Management for European Centralised Procedures.
Responsibilities:
* Plan and track activities related to regulatory submissions in the EU.
* Communicate effectively with stakeholders, providing updates on regulatory submission dates, status, and minor/significant product information changes.
* Provide logistical support for meetings with EMA and national Health Authorities, as required.
* Collaborate with the European Regulatory Liaison team to develop European strategy through research and membership of multidisciplinary Project Teams.
Your Qualifications
* PhD-level scientific background is desired.
* A minimum of 3+ years of direct or relevant experience in European regulatory procedure, with a strong focus on LCM and MAA.
* Excellent communication, organisational, and attention-to-detail skills, with in-depth knowledge of EU Regulatory requirements.
About Our Client
Our client is a global leader in enabling pharma, biotech, and consumer health partners to optimise product development, launch, and full life-cycle supply for patients worldwide.