Job Description

Job Title: CMC RA Associate Director I Submission Excellence & Project ManagementCareer Level - EIntroduction to role:Join us at AstraZeneca as a CMC RA Associate Director I Submission Excellence & Project Management. This role is a unique opportunity to manage projects or complex product ranges across the portfolio throughout the product lifecycle. You will be accountable for interfaces with CMC Product leads, proactively partnering with stakeholders across AZ organisation to help deliver and implement innovative risk-based regulatory strategies. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards and timelines.Accountabilities:You will be responsible for managing the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle. This includes leading CMC submission management teams, applying project management expertise, highlighting resource needs for product as appropriate for effective planning purposes, and leading/contributing to cross SET non-drug projects. You will also participate in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.Essential Skills/Experience:University Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.Minimum 13 years of Relevant experience from biopharmaceutical industry, or other relevant experienceBreadth of knowledge of manufacturing, project, technical and regulatory management.Strong understanding of regulatory affairs globallyStakeholder & Project managementDirect Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or complex biologic productsUnderstanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodiesLean capabilityQuality Risk ManagementExperience managing resource requirements for pivotal projects.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. 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 to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what\'s next. We are part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions.Are you ready to take ownership and be recognised as leaders across the business? Embrace the opportunity to lead across levels, departments and drug modalities. Apply now!Date Posted 05-Jul-2024Closing Date 12-Jul-2024AstraZeneca 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.

AstraZeneca