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Job Title: iCMC Regulatory Affairs Manager ICareer Level - D1Introduction to roleAs an iCMC RA Manager I, you will effectively handle the production of Chemistry, Manufacturing, and Control (CMC) documentation for designated product ranges to meet the needs of both AstraZeneca and our customers. You will project manage international CMC regulatory submissions, ensuring that project activities and documentation are delivered to the required standards across the product lifecycle. You will chip in to and lead the regulatory CMC components of business-related projects, maintaining effective communication with collaborators and project team members to ensure relevant timelines and regulatory commitments are met. Additionally, you will ensure the application of international CMC regulations and guidance within AstraZeneca and chip in to the development of new guidance, policy, and processes.AccountabilitiesManage the timely preparation (including authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including marketing authorization applications and all post-approval activities.Accountable for delivering “submission ready” CMC modules to internal and external regulatory team members in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.Document maintenance and communication of Health Authority approval status.Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.Demonstrate project management expertise with the ability to adapt to changing situations to ensure on-time delivery.Share learnings from own projects with colleagues/within functions.Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence and optimize proposed submission content.Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team.Contribute to business process optimization activities to reduce waste and ensure efficiency.Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments.Apply GxP principles according to the stage of the product lifecycle.Responsible for organisational change as assigned.Understand the application of appropriate risk management across own activities.Demonstrate research skills in understanding regulations and guidance from different regulatory agencies.Essential Skills/ExperienceUniversity degree in a science or technical field such as pharmacy, biology, chemistry, or biological science.Minimum 8 years of proven experience from the biopharmaceutical industry or other relevant experience.Breadth of knowledge of manufacturing, project, technical, and regulatory management.IT skills.Collaborator & project management.Professional capabilities: Regulatory knowledge.Desirable Skills/ExperienceKnowledge of the drug development process and regulatory submissions.Understanding of current regulatory CMC requirements.Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products such as monoclonal antibodies or complex biologic products.Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies.Lean capabilities.When we put unexpected teams in the same room, we fuel ambitious 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. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're 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 committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines that achieve the best results for patients in need and healthcare professionals. Our innovative mindset drives us to think broadly about patients and what it takes to prevent and treat diseases. We are a diverse and open-minded team that values different skills and experiences, empowering us to make quick decisions and influence drug development strategies. Our science-driven approach ensures that our regulatory strategy is appreciated and valued, allowing us to bring life-changing medicines to patients.Ready to make a difference? Apply now to join our dynamic team!Date Posted02-Jan-2025Closing Date21-Jan-2025AstraZeneca 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.
