AstraZeneca seeks a Director of International CMC Regulatory Affairs for cell and gene therapies based in Barcelona. This strategic leadership role oversees regulatory compliance and submission strategies across clinical development, registration, and post-approval stages, representing the organization with health authorities and cross-functional teams.
Responsibilities
- Develop and implement international CMC regulatory strategies across development, registration, launch, and lifecycle management
- Interpret global regulations and translate evolving health authority expectations into strategic advice
- Lead or coordinate high-quality CMC submissions including BLAs, MAAs, master files, and regulatory briefing materials
- Represent organization externally with trade associations and health authorities on emerging regulations
- Lead cross-functional teams, manage regulatory risks,



and drive consistent approaches to CMC dossier management

Requirements
- 10+ years CMC regulatory affairs experience (or 8+ with master's degree, 6+ with doctorate)
- Direct experience developing and commercializing cell therapy products
- Deep knowledge of integral CMC regulatory requirements and biologic development processes
- Demonstrated ability to lead complex submissions and health authority interactions
- Strong risk management, problem-solving, and project leadership skills
- Degree in life sciences, pharmacy, biology, chemistry, biotechnology, or related discipline
- Experience with ex vivo cell therapies, in vivo gene therapies, and biologics

📌 Director, International CMC Regulatory Affairs (España)
🏢 AstraZeneca
📍 España