Descripción de la oferta
Introduction to role:This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management experience and a track record of advancing innovative therapies through key clinical development milestones.As a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD is solutions-oriented and a key contributor to regulatory strategy development, the identification of submission risks and opportunities, and drives high quality global regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.Accountabilities/ResponsibilitiesPartner closely with members of the global regulatory team, to define stage appropriate regulatory strategy in alignment with global regulatory requirements and expectations, to bring innovative cell-based gene therapies to patients.Closely monitor evolving global and regional regulatory guidelines, policies, and procedures to support efficient, scientifically rigorous, and patient-centric development plans.Lead and contribute to the planning, preparation, review, and submission of regulatory submissions (e.G., IND, CTA, GMO, BLA, IVDR) s for cell-based gene therapies across all regions, ensuring proper documentation and compliance with internal and external standards.Advise the regulatory and cross-functional teams of available opportunities to accelerate development by evaluating risks and identifying potential solutions to address regulatory hurdles.Participate in meetings withHealth Authoritiesto gain direct exposure to regulatory feedback and enable:Contribution to submission delivery strategies for all dossiers and application types that are responsive to health authority adviceAnalysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.Support some operational and compliance activities for assigned projects.May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.Contribute to governance meetings and process improvement.Minimum RequirementsBachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.5+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience.Thorough Knowledge of drug development.Strong project management skills.Leadership skills, including experience leading multi-disciplinary project teams.Preferred ExperienceMaster’s, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline.7+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience.Managed complex regulatory deliverables and submissions across projects/products.Managed CTA or first wave Marketing Applications and/or LCM submissions with application of IVDR/GMO.Knowledge of AZ Business and processes.Experience and expertise using Artificial intelligence tools.Skills and CapabilitiesExcellent written and verbal communication skills.Cultural awareness.Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.Proficiency with common project management (e.G., MS Project) and document management tools.Ability to work independently and as part of a team.Influencing and stakeholder management skills.Ability to analyze problems and recommend actions.Continuous Improvement and knowledge sharing focused.Internal and External Contacts/CustomersGlobal Regulatory Leads (GRLs)Regional Leads (eg, US, EU international RADs)Lead RPMRegulatory skill group in CGTMarketing CompaniesHealth AuthoritiesExternal Collaboration partnersWhy AstraZeneca?At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.Date Posted31-jul-2026Closing Date13-ago-2026AstraZeneca 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.#J-18808-Ljbffr
