Job Title
European Regulatory Procedural Strategist
About the Role
We are seeking a skilled European Regulatory Procedural Strategist to join our team on a contract basis for 12 months.
Key Responsibilities:
* Manage the operational and procedural aspects of European regulatory filings within the Centralised Procedure, working closely with the European Regulatory Liaison group and regional/global functions.
* Plan and track activities related to regulatory submissions in the EU, ensuring timely preparation and filing of Marketing Authorisation Applications and Life Cycle Management for European Centralised Procedures.
* 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 Background
* PhD-level scientific background (desired).
* At least 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.
Location
This role is based at our client's site in Uxbridge, with a 50/50 hybrid working arrangement.