Our client provides cross-functional consulting services, to support pharma, biotech and medtech organizations to achieve sustainable success and continuously uphold industry standards while navigating dynamic and international regulatory landscapes across the lifecycle of medicinal products, devices, IVDs and combination products. They also provide personalized, expert-led, cross-functional support in development, regulatory affairs, quality assurance, pharmacovigilance, medical and regulatory communications, market access, public affairs, healthcare compliance, project management, establishing and scaling-up companies.
EU Regulatory Lead
Currently, seeking a highly experienced EU Regulatory Lead to support with the planning, preparation and submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
This role is an initial 6–12-month contract to be 100% remote anywhere in Europe with 50% -70% FTE
Main Responsibilities:

Provide strategic EU regulatory leadership and advice for the preparation and submission of the MAA to the EMA.




Lead and provide strategic guidance on the EU regulatory submission strategy, ensuring alignment with applicable EMA requirements and timelines.
Act as the primary regulatory representative for the client in interactions with EMA and other relevant European regulatory stakeholders.
Represent the company professionally and effectively in regulatory meetings, discussions, and submission-related interactions.
Provide regulatory input and oversight throughout the preparation of the MAA, including review of key regulatory documentation and submission components.
Work closely with the client, partner pharmaceutical company, and internal/external stakeholders to ensure alignment on regulatory strategy, responsibilities, timelines, and deliverables.
Provide strategic advice on regulatory questions, potential risks, issues, and opportunities associated with the EU development and submission pathway.
Coordinate

📌 Freelancer EU Regulatory Lead (España)
🏢 CTC Resourcing Solutions
📍 España