Qw-014 - Senior Global Regulatory Affairs Manager

.A Career with Purpose Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world.We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people.Our shared values create a unique culture that guides our actions and defines who we are.You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging.We believe that creating opportunities for our people to develop their skills is crucial to our growth and success.If you are inspired by changing the lives of patients all over the world, we'd love to hear from you.About the Role We have an opportunity for a Senior Regulatory Manager within the Clinical Development team.You will be a highly skilled and experienced regulatory expert, with recent hands-on experience of successful clinical trial submissions within the Latin America and/or Asia-Pacific regions.You will be an accomplished communicator, adept at conveying complex regulatory information in simple format.You will be driven and self-motivated able to prioritise your own workload and deliver projects to time-and-target.This is an exciting opportunity to join a growing Regulatory team contributing to the Bionical Emas vision of bringing life-changing medicines to patients around the world.Interested? Let's get in touch What will your job look like?Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone regulatory project,with guidance from senior staff as appropriate Develops and adheres to a regulatory submission plan, in consultation with Client representative(s) and internal stakeholders and in accordance with project timelines Performs and/or oversee global clinical trial regulatory and ethical applications and maintains and closes-out approvals; accountable for the delivery of regulatory and ethical submissions to time-and-target Competently writes regulatory and/or technical documents with minimal review by senior staff Establishes relationships with many customers; may meet face-to-face without rest of team to discuss regulatory issues and present lessons learned.Adopts a proactive and flexible approach to resolve any issues Undertakes detailed review and management of budgets related to projects, including out of scope activities