Regulatory Affairs Director
AstraZeneca Barcelona
Experteer Overview
In this role, you drive global or regional regulatory strategy for assigned products, shaping the path to rapid approvals and competitive labeling. You lead cross-functional teams through major health authority interactions and NDA/IND/CTA processes, acting as the face of the company to authorities.You guide the Global Regulatory Strategy Team and contribute to overall product strategy and lifecycle plans. Your work spans regulatory risk assessment, dossier preparation, and negotiations to secure approvals. You join a mission-driven company committed to diverse, high-impact medicines.
Compensaciones / Beneficios- Lead regional or global regulatory strategy for products to achieve rapid approvals and favorable labeling
- Head cross-functional teams in health authority interactions and prepare strategy-focused briefing documents
- Lead and coach the Global Regulatory Strategy Team (GRST) and participate in coaching
- Represent Regulatory Affairs on Global Product Teams when required and provide strategic regulatory advice
- Ensure timely delivery of regulatory milestones, assess regulatory risks, and manage risk mitigations
- Oversee global dossier construction and core labeling, and coordinate product maintenance and compliance for marketed brands
- Collaborate with regional regulatory affairs and marketing to influence guidance and strategy
- Initiate and deliver regulatory documents and lead negotiations with health authorities
- Assess emerging data against project aspirations and update senior management on risks
- Advanced degree in a science-related field
- At least 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
- Solid knowledge of regulatory affairs in at least one therapeutic area (early and late development)
- Strong strategic thinking, influencing, initiative, leadership, and communication skills
- Ability to think strategically, evaluate regulatory risks, and operate in a high-profile development program
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AlmirallSant Feliu de Llobregat, 6 km de Barcelona
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Responsabilidades
• Bachelor’s degree in Life Sciences or Pharmacy; advanced degree preferred
• Minimum 8 years of experience in Regulatory Affairs in the pharmaceutical industry
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