European Regulatory Procedural Strategist Role
We are seeking an experienced European Regulatory Procedural Strategist to join our team at a global pharmaceutical company based in Uxbridge on a contract basis for 12 months.
Salary: Up to £35.00 per hour (PAYE) inside IR35
Responsibilities:
* Manage the operational and procedural aspects of European regulatory filings, including new Marketing Authorisation Applications' preparation and filings and Life Cycle Management for European Centralised Procedures.
* Plan and track activities related to regulatory submissions in the EU.
* Communicate regulatory submission dates, status, and changes to relevant parties.
* Provide logistical support for meetings with EMA and national Health Authorities.
* Collaborate with the European Regulatory Liaison group to develop European strategy through research and membership of multidisciplinary Project Teams.
Your Background:
* You should have a solid scientific background (PhD level desired).
* At least 3+ years of direct experience in European regulatory procedure is required.
* You should be able to work on LCM and MAA with minimal supervision and take a leadership role for non-project based support.
* Great communication, organisation, and attention-to-detail skills, as well as in-depth knowledge of EU Regulatory requirements, are essential.
About Our Client:
Our client is the global leader in enabling pharma, biotech, and consumer health partners to optimise product development, launch, and full life-cycle supply for patients around the world.
Location:
This role is based at our client's site in Uxbridge, with 50/50 hybrid working.
Requirements:
* You must hold entitlement to work in the UK.