Barcelona
- Spain (3 days working from the office and 2 days working from home)Introduction to the roleThe RAD provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s). The RAD serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead. As a GRL the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Typical AccountabilitiesAccountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST.
May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs)



providing strategic Regulatory advice and be accountable for all Regulatory activitiesAccountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Provide team leadership and participate in coaching, and performance feedback to members of the GRST.
Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
Ensures appropriate planning and construction of the integral dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands.
Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Ability to work strategically within a complex, business critical and high-profile development program.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #

📌 Regulatory Affairs Director (España)
🏢 AstraZeneca
📍 España