Associate Regulatory Affairs Director - Respiratory & Immunology

Location: Barcelona, Spain (on-site) - 3 days working from the office.

Are you passionate about science and experienced within drug development, project management and regulatory affairs?

At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We need people who share our passion for science and determination to meet patients’ needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative treatments for Respiratory and Immunology (R&I) diseases.

We are now looking for passionate colleagues to join our Regulatory Affairs Management team as Associate Regulatory Affairs Directors (ARAD). With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and large molecules.

The role is based at AstraZeneca’s new R&D site in Barcelona, Spain. We’re proud to be opening a hub in Barcelona, where our dynamic and collaborative team will make greater strides in bringing life-changing medicines to patients worldwide. This new hub offers exciting opportunities at the forefront of science, and the chance to be part of a team that learns and grows together. We need self-starters with the skills, determination, and passion necessary to change lives.

Our Barcelona hub has been created to achieve the next wave of breakthroughs that help us do what’s never been done before, as we expand our global footprint. Harnessing data and using the best technology solutions available allow us to positively impact science.  Up to 500 R&D specialists will be hired to work at our hub in the coming two years. We want you to join us in transforming medicine and developing new treatment options that will change the lives of patients globally.

What you’ll do

Working in the role as an AssociateRegulatory Affairs Director (ARAD), you will lead the end-to-end planning, coordination, and execution of assigned regulatory procedures and submissions. With your knowledge and strong project management skills, you will be a key contributor to the regulatory submission strategy, identifying submission risks and opportunities, while leading complex regulatory applications and managing procedures through approval.

In this role you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions making sure that the regulatory project delivery and process improvements are in line with business priorities.

Your main accountabilities/responsibilities:

• Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective.
• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents e.g., response documents, study protocols, Periodic Safety Reports and provide regulatory input.
• Lead multi-disciplinary project teams.
• Support operational and compliance activities for assigned regulatory tasks.
• Provide coaching, mentoring and knowledge sharing within the regulatory skill group.
• Contribute to process improvement.
• Identify regulatory risks and propose mitigations to appropriate member of cross functional teams.

Essential for the role

• Relevant University Degree in Science or related field.
• Extensive Regulatory experience (3+ years) within the biopharmaceutical industry, or at a Health Authority, or other proven experience.
• Thorough drug development knowledge.
• Strong Project management skills including tools e.g. MS Project.
• Excellent written and verbal communication skills.
• Leadership skills, including experience leading multi-disciplinary project teams.

Desirable for the role

• Knowledge of the Respiratory & Immunology therapy area.
• Managed first wave Marketing Applications and/or Life Cycle Management submissions.
• Managed complex regulatory deliverables across projects/products.
• Veeva Vault experience.
• Cell Therapy experience.
• Demonstrate a high ability to use digital tools and solutions and have a broad working knowledge of emerging technologies e.g., Artificial Intelligence and Machine Learning.

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.