Regulatory Affairs Manager (Medical Device) (Permanent)

Regulatory Affairs Manager Type: PermanentDeliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities, including project leadership. Achieve timely delivery of clinical trial approvals and maintain high regulatory compliance standards for the UK through provision of local regulatory expertise. Support the development of AstraZeneca investigational and in-licensed/co-development products through valued contributions to cross-functional projects, study feasibility questionnaires, scientific advice meetings, and other related activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.Regulatory Compliance & Governance (0-10%)Commercial Support (0-15%)Formulate and Influence Regulatory Strategy (0-15%)4+ years experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company.~ Post-Brexit UK Regulatory experience~ Business Relationship Management and ability to navigate and coordinate cross-functional interactions~ Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role~ Regulatory Strategy Development~ Use of external regulatory environment and scientific knowledge skills to build a productive, positive and trustworthy relationship with local health authorities to drive meaningful interactions to the benefit of patients~ Optimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines~ Development of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies~ Application of the knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities~ Therapy Area Expertise in one of Oncology, injectable biologics, medical devicesExperience in creating and delivering regulatory strategies for Orphan drugs applications and/or paediatric indicationsAssessment of, planning for & managing the impact on partners arising from changes & applying change management techniques to appropriately engage partnersA robust understanding of the disease and therapeutic area including the regulatory and health technology assessment environment in the major markets, competitor landscape, and predictable barriers/obstacles in developmentAt AstraZeneca, we change the practice of medicine by generating compelling medical evidence that helps physicians better treat patients at every point in their journey….