.Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!At AstraZeneca, we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. We put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality.AstraZeneca's pipeline of innovative medicines is growing within Immunology Cell Therapy, one of our major therapy areas. To meet the increasing demand for regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior Director level). You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs.This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.You will be responsible for:Providing regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.Leading and supporting staff in preparation for regulatory authority meetings and providing input to submission strategy and other critical regulatory documents. May represent AstraZeneca as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.Providing input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.Actively collaborating with Senior Management and Enterprise functions (e.G., Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.Staying up to date on the latest regulatory requirements and trends.Providing support as needed to Business Development activities of the Enterprise, notably supporting Regulatory due diligence, gap assessment, and resource needs
