Regulatory Affairs Director

About the role

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership for the development, commercialization, and lifecycle management of assigned products. Based in Barcelona, the role works in a hybrid model (3 days onsite, 2 days remote) and serves as the global or regional regulatory lead, influencing health authorities to achieve favorable outcomes.

Key responsibilities

• Develop and implement regional or global regulatory strategies to secure rapid approvals and competitive labeling.
• Lead cross‑functional teams in major regulatory submissions (NDA, IND/CTA, BLA) and health‑authority interactions.
• Head the Global Regulatory Strategy Team (GRST) or contribute as a regional member, providing strategy, coaching, and performance feedback.
• Prepare regulatory strategy documents, target product labeling, and negotiate with health authorities.
• Deliver all regulatory milestones, assess risk, and define mitigation plans.

Required profile

• Extensive experience in regulatory affairs within pharma/biotech, with proven leadership of global or regional regulatory programs.
• Strong ability to influence health authorities and drive strategic product and clinical decisions.
• Demonstrated track record of successful NDA/BLA approvals and health‑authority negotiations.
• Excellent communication and team‑leadership skills.

Required skills

• Regulatory submission expertise (NDA, IND/CTA, BLA).
• Regulatory strategy development.
• Health‑authority interaction and negotiation.
• Labeling strategy and preparation.