Regulatory Affairs Director

About the role

AstraZeneca is looking for a Regulatory Affairs Director (RAD) in Barcelona, working 3 days in the office and 2 days from home. The RAD provides strategic and operational regulatory leadership for the development, commercialisation and life cycle management of assigned product(s), acting as global regulatory lead on early-stage projects or specific indications of larger programmes, or as regional regulatory lead. The role contributes to product and clinical strategy and influences regulatory authorities through regular contact to improve regulatory outcomes.

Key responsibilities

• Lead the development and implementation of the regional or global regulatory strategy for a product or group of products, aiming for rapid approval with competitive labelling, including health authority engagement and expedited programmes
• Lead cross-functional teams in major health authority interactions, from briefing document strategy and rehearsals to moderating meetings
• Lead a Global Regulatory Strategy Team (GRST) of members from regions, emerging markets, RA CMC, Labelling and the submission team, and coach and give performance feedback to them
• Represent Regulatory Affairs on Global Product Teams where required, and deliver all regulatory milestones, assessing regulatory risks and mitigations
• Lead preparation of the regulatory strategy document and target product labelling, and negotiate with health authorities
• Ensure proper planning of the global dossier and core prescribing information, and cover product maintenance, supply and compliance for marketed brands
• Partner with marketing companies and regional regulatory affairs staff to shape guidance

Required profile

• Advanced degree in a science-related field and/or other appropriate knowledge or experience
• At least 5 years of regulatory drug development experience and experience with major health authority interactions
• Prior experience with phase 3 design and end-of-phase 2 health authority interactions desired
• Contribution to a regulatory approval, including leading a response team and labelling negotiations, is a plus
• Desirable: broad experience across several areas of regulatory affairs, in small molecules and biologics, and in a complex, business-critical programme

Required skills

• Solid knowledge of regulatory affairs in at least one therapeutic area in early and late development
• Strategic thinking, strategic influencing, leadership and excellent oral and written communication
• Ability to evaluate risks to regulatory activities
• Desirable: understanding of drug development principles such as benefit/risk, dose selection and statistical design