Regulatory Affairs Director

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

The Regulatory Affairs Director 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. Contributes significantly to overall product and clinical strategy. The role plays a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. The RAD leads cross- functional Teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. As a GRL the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice. The RAD serves as the face of the company with Health Authorities.

Accountabilities

• Accountable 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 health authority engagement strategy and considerations of expedited regulatory programs.

• Lead cross-functional Teams in major health authority interactions. 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 activities.

• Accountable 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. Lead preparation of the regulatory strategy document and target product labeling.

• Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in coaching, and performance feedback to members of the GRST.

• Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.

• Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.

• Ensure appropriate planning and construction of the global 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.

Essential for the role

• An advanced degree in a science related field and/or other appropriate knowledge/experience.

• At least 7-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.

• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

• Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

• The ability to think strategically and critically and evaluate risks to regulatory activities

Desirable for the role

• A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.

• 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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. 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.