Job Title: Regulatory Affairs Manager - Respiratory and Immunology Job Location: London, England, United Kingdom Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Regulatory Search roles Keyword Search City, State, or ZIP Search jobs Regulatory Affairs Manager - Respiratory and Immunology Location London, England, United Kingdom Job ID R-211990 Date posted 06/11/2024 Apply Regulatory Affairs Manager Location: London St Pancras Competitive Salary, Bonus Benefits Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product responsibilities, manage the regulatory process, and negotiate with regulatory agencies to provide rapid approvals with competitive labelling. Accountabilities As a Regulatory Affairs Manager, you will Identify regulatory strategies to support commercial and business objectives and company efficiencies. Plan and execute workload for the defined product responsibilities and agreeing plan with Regulatory Affairs Lead Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications) Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety and supply chain functions. Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirements Assure appropriate standards and policies for all technical aspects of the company’s activities in Regulatory Affairs are adhered to Provide regulatory input/solutions to supply and stock issues Liaise with Operations to manage pack changes and ensure labelling compliance Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence Provide strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence Project manage and deliver projects of commercial strategic value Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues Ensure appropriate cross-functional input into the delivery of optimal licence strategies Keep up-to-date with developments in the Regulatory environment and share this knowledge across the department and beyond, in the business interest Ensure optimal departmental processes through continuous review Actively contribute to the development, coaching and training of the department, including new starters Proactively manage the regulatory process for clinical trials for UK Essential Skills/Experience Life Sciences Degree or appropriate professional qualifications Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role Desired Skills/ Experience Therapy Area Expertise in Respiratory Immunology Experience in creating and delivering regulatory strategies Postgraduate qualification When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we are driven by results and use our unique blend of science and commercial knowledge to spot opportunities and drive outcomes. We are redefining the future of biopharmaceuticals, working towards our vision to be the leader in Cardiovascular, Renal, Metabolism, Respiratory and Immunology by 2025. Our patient-first approach informs every decision we make. Here we believe in digging deep to understand what patients truly need. Were empowered to stay at the forefront - with the resources and support of a leading pharma, and the nimbleness and flexibility of a smaller business. Are you ready to fuel your ambition and break new ground? Join us in turning our productive pipeline into a reality to impact patients lives Apply today Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram If you have site, country or departmental social media then feel free to switch any of the above links. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. AstraZeneca 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. 50056707 E RGRO Apply View saved jobs Describe what the Trainee Programme has given you in terms of opportunities to progress in the arena of regulatory writing. Transcript Hi, my name is Solomia and before joining AstraZeneca, I was a Quality Assurance Specialist. I think the training programme is great because through the different activities that we did, I could identify the key soft skills that are required for a Clinical Regulatory Writer. I could also identify that I do have some of those skills. That gave me an extra confidence that I could grow within the role, and the confidence necessary to take control of my development. % buffered00:00 00:41 Sorry, your browser doesnt support embedded videos. Video length: 41 seconds0:41 Hi, my name is Solomia and before joining AstraZeneca, I was a Quality … Solomia Specialist Clinical Regulatory Writing Explore the local area Take a look at the map to see what’s nearby. View All of Our Available Opportunities 【AstraZeneca】【RI】Market Development Manager, Biologics penetration Osaka, Ōsaka, Tokyo Clinical Research Associate Wilmington, Delaware Senior Functional DevOps Engineer Zapopan, Jalisco Thought Leader Liaison, US Metabolic - NE Wilmington, Delaware We’ll keep you up to date Sign up to be the first to receive job updates Email Address Interested InPlease select a category or location option. Click “Add” to create your job alert. Category Location Selected Job Alerts Confirm Email By signing up, I acknowledge I have read the AstraZeneca privacy policy, and I wish to receive email communications and SMS communications. I understand I can opt-out from receiving email and SMS communications at any time. About Us We are AstraZeneca, one of the world’s most forward-thinking and connected BioPharmaceutical companies. Explore our world. Life at AstraZeneca At AstraZeneca, our purpose is to help patients all over the world by delivering life-changing medicines as one collaborative team. Inclusion Diversity The success of AstraZeneca is founded on innovation, creativity and diversity. Discover what this means for you. Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity. see our latest Glassdoor reviews here Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please use the below Lifelancer link to Apply and view similar roles. https://lifelancer.com/jobs/view/81c4f685c922fdcf34e171eb71ba0e5f Apply on Lifelancer Platform