Job Description

Job Title :Regulatory Affairs Group Director
Career Level : FLead the way for a new breed of solutions-oriented RegulatorsChampion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug developmentBe part of the team where you are empowered to follow the scienceBe part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..ABOUT ASTRAZENECAAt AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and developmentABOUT THE TEAMWe are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.ABOUT THE ROLE / CapsuleResponsible for recruitment and line management of 10+ regulatory professional staff. Contribute to the strategy, direction and efficient operation of the Regulatory TA organisation as well as the RAM community. Provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group.Take on responsibility as subject matter expert to drive continuous improvement or change project.Typical AccountabilitiesProvide leadership, coaching and line management for 10+ direct reports. Ensure the principles of both individual and team performance development are used to develop staff to their full potential.Attract and recruit talent. Be an ambassador for the RAM group, able to engage stakeholders and clearly articulate the RAM roles and responsibilities.As a member of the Leadership Team for the TA Regulatory Affairs Management (RAM) group, proactively contribute to the strategy, direction and efficient operation of the group. Develop and deliver departmental performance targets for the TA Regulatory organisation.Assignment of capable RAM resources to meet the drug project and improvement project needs in collaboration with the wider Regulatory TA leadership team and Lead RPMs, ensuring cost effective and flexible resource management which is aligned with TA priorities and specific Global Regulatory Execution Teams(s) (GRET(s)) as required.Contribute to management of the budget and head count, identifying budget priorities taking careful note of global portfolio changes and business needs.Ensure own work and work of direct reports and GRETs adheres to and remains in compliance with AZ standards, processes, AZ group policies and corporate responsibilities.Has an in-depth regulatory knowledge and understanding of RAM roles, Submission Excellence and Regulatory Operating Model and can support individuals as needed with typical activities at a global and/or regional level to ensure delivery of project objectives on time and to appropriate quality.Drive a culture of continuous improvement, learning and knowledge sharing.Lead development and continuous improvement of expert and/or process area and/or drug project work.Collaborate with the wider global regulatory organisation (cross TA and CMO) to drive the development of leading edge RAM capabilities as well as system and process improvement driving productivity gains.Influence the image of the business externally.Education, Qualifications, Skills and ExperienceEssentialUniversity Degree in Science or a related disciplineMinimum of 12 years of regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including regulated marketsExtensive regulatory experience within the biopharmaceutical industry, or experience at a health authorityKnowledge of regulatory procedures and legislation for drug development, throughout the product lifecycleProven successful leadership and project management experienceProven ability to develop others to meet personal aspirations and business needsProven ability to drive and implement change and improvement projectsStrong influencing, stakeholder management and negotiating skillsExcellent written and verbal communication skillsDesirableManaged first wave Marketing Application and/or LCM submissionsManaged complex regulatory deliverables across projects/productsKnowledge of AZ business and processes.Facilitation skillsWHY JOIN US?We believe theres always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughoutSO, WHATS NEXT?Are you already envisioning yourself joining our team? Good, because wed love to hear from you! Click the link to apply and well be in touch as soon as we can.WHERE CAN I FIND OUT MORE?Our Social Media, Follow AstraZeneca on LinkedInWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.Date Posted 03-Jul-2024Closing Date 11-Jul-2024AstraZeneca 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.

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