Barcelona-based Global Regulatory Strategy Director

AstraZeneca plc

Barcelona

Hybrid

EUR 140,000 - 190,000

Full time

5 days ago

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Job summary

AstraZeneca plc in Barcelona, Spain seeks an experienced Regulatory Affairs Director to lead regional or global regulatory strategy. You will drive major health authority interactions, shape filing strategies, and coordinate NDA/IND submissions while guiding a cross-functional team to deliver on regulatory milestones.

The role requires strategic leadership, strong communication skills, and a proven track record in regulatory science across therapeutic areas.

Qualifications

Advanced degree in a science-related field.
5+ years of regulatory drug development experience with major Health Authority interactions.
Experience with phase 3 design and end-of-phase 2 health authority interactions is desirable.
Ability to think strategically and evaluate regulatory risks.

Responsibilities

Lead the regional or global regulatory strategy for products to enable rapid approvals and competitive labeling.
Direct cross-functional teams in health authority interactions and major submissions (NDA/IND/CTA).
Lead the Global Regulatory Strategy Team (GRST) and coach members on performance feedback.
Represent Regulatory Affairs on Global Product Teams and oversee regulatory milestones and labeling negotiations.
Coordinate development of regulatory documents and ensure alignment with product strategy and risk mitigation.