Regulatory Affairs Manager – Respiratory and Immunology

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About the role

Regulatory Affairs Manager – Respiratory and Immunology Do you have in-depth knowledge within Regulatory Affairs and want to develop your skills within project management ? At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of Clinical trials , from initial submissions to end of trials, worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to driving submission excellence. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Respiratory and Immunology Therapy Area . At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients’ lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we’re focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth. The role We are looking for a member to join our Regulatory Affairs Management team within the Respiratory and Immunology Therapy Area, in the role as Regulatory Affairs Manager (RAM). The role is a permanent position based in Warsaw, Poland What you’ll do Working in the role as Regulatory Affairs Manager (RAM) , you will have a unique opportunity to work in cross functional teams, with all phases of clinical trials across geographic regions. With your knowledge, you will contribute to regulatory submission Excellence, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Your main accountabilities/responsibilities: · Understand the regulatory framework, including regional requirements and emerging trends, for clinical trial applications and investigational new drug submissions across relevant regions. · Provide regulatory input on procedural and documentation requirements defined by Health Authorities for assigned deliverables. · Lead or contribute to the planning, preparation, coordination and delivery of CTA/IND submissions throughout the clinical study lifecycle. · Coordinate cross-functional contributions to ensure submission components are complete, consistent, inspection-ready and delivered to agreed timelines. · Provide regulatory review of documents, including study protocols, response documents, safety-related documents and other submission content. · Identify regulatory risks, dependencies and opportunities, and propose pragmatic mitigations to stakeholders. · Support operational and compliance activities, including submission content planning, submission tracking, document management and maintenance of the Trial Master File, where applicable. · Provide coaching, mentoring and knowledge sharing within the RAM skill group and the CTA/IND CoE. · Contribute to process improvement, simplification, standardisation and the effective use of digital tools across CTA/IND delivery. Do you have the essential qualifications for this role? To be successful in this role, we believe that you have an University degree in science or a related field and a deep understanding of and proven experience from Regulatory Affairs, within the biopharmaceutical industry and/or at a health authority. This role also requires knowledge of drug development and hands on experience with CTA and/or IND submissions. We believe that you possess excellent project management

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