Pharma Regulatory Project Manager

Job Offer – Pharma Regulatory Expansion Project Manager (Spain)

Location : Catalonia (Hybrid / Flexible)

We are looking for a Pharma Regulatory Expansion Project Manager to support international pharmaceutical companies in establishing their operations in Spain. This role is ideal for a professional with strong expertise in Spanish pharmaceutical regulations, licensing, compliance, import procedures, and market-entry requirements , combined with solid project management skills.

The consultant will function as a trusted advisor , guiding clients through all steps required to operate legally and effectively in Spain, including documentation, timelines, regulatory obligations, and coordination with local authorities and partners.

Your Mission

As a Pharma Regulatory Expansion Project Manager, you will :

• Lead end-to-end projects for the set-up of pharmaceutical operations in Spain , including regulatory, legal, and compliance requirements.
• Advise clients on all necessary licenses, registrations, certifications, and inspections needed to import, store, and distribute products in Spain.
• Define and communicate the roadmap, timeline, key milestones, and critical steps for regulatory approval and operational readiness.
• Coordinate interactions with Spanish authorities , including AEMPS, customs, health agencies, and GMP / GDP inspectors.
• Identify the required legal entity structure , authorized representative models, or alternative pathways to operate in Spain.
• Guide clients on importation processes , documentation, customs clearance, and logistics compliance.
• Evaluate and recommend Spanish partners (3PLs, regulatory agencies, warehousing providers, authorized representatives) to support local operations.
• Ensure full compliance with GMP / GDP standards, pharmaceutical legislation, and EU regulatory frameworks .
• Prepare and manage all regulatory documents, SOPs, technical files, and compliance documentation.
• Act as the main point of contact, overseeing project progress, risks, and deliverables.

Desired Profile

What We Offer

📩 Interested?

Send your CV to nacho.cornudella@meotec.com with the subject : Pharma Regulatory Expansion PM – Spain