▷ Immediate Start Cmc Regulatory Affairs Associate Director Ii

Job Title CMC Regulatory Affairs Associate Director IIGlobal Career Level EIntroduction to roleAre you a strategically focused Regulatory CMC professional eager to play an integral part in bringing life-changing medicines to patients If so please read on As a CMC Regulatory Affairs Associate Director II you will provide essential CMC Regulatory Strategy operational tactical and decision-making expertise for projects and complex product ranges from early clinical development through to launch and post-approval lifecycle management for global markets You will represent CMC Regulatory Affairs across various business networks including Pharmaceutical Development Project teams Global Regulatory Strategy Teams Global Supply Teams and Global Quality and Operations You may also lead the development of new guidance policy and processes facilitating high-quality partnerships within and external to AstraZeneca Your role will support CMCRA for products projects and or specialist areas with a deep understanding of the complexities and challenges required for Dossier submissions and proven project management skills Accountabilities- Provide CMC RA expertise across business functions and potentially lead key business improvement initiatives - Offer strategic CMC RA expertise and direction for CMC submissions across the product lifecycle supporting novel strategies and new approaches from technical functions - Lead CMC-related interactions with Health Authorities when necessary - Provide regulatory strategic guidance in support of operational initiatives such as complex accelerated projects and post-approval changes - Contribute to or lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca - Share knowledge by leading contributing to Communities of Practice across groups or within a business unit - Manage high-level risk by making complex judgments and developing innovative solutions including proactive risk management and mitigation - Provide clear concise guidance on current CMC regulatory requirements to support business tactical and strategic planning - Support the development and implementation of novel strategies in CMC regulatory affairs to enhance efficiency and flexibility in the CMC dossier - Contribute to cross-therapeutic non-drug projects and support business processes to ensure accelerated submissions launch activities regulatory information management and regulatory compliance on behalf of AstraZeneca Essential Skills Experience- Bachelor s degree in Science Regulatory Sciences or Pharmacy - Breadth of knowledge of manufacturing project technical and regulatory project management - Strong understanding of regulatory affairs globally - Direct Regulatory Affairs CMC experience with submissions for synthetics and or biologic and biotechnology-derived products - Stakeholder Project management Desirable Skills Experience- Master s degree or PhD in Science Regulatory Sciences or Pharmacy - Business financial and supply chain understanding awareness - Experience with regulatory health authority interactions inspections and or external advocacy regulatory policy - Experience in line and or matrix leadership - Experience with clinical development of innovative pharmaceutical APIs and Drug Products 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 that achieve the best results for patients in need and healthcare professionals Our innovative mindset drives us to think broadly about patients needs and what it takes to prevent and treat diseases We are valued for our influential work in shaping drug development and gaining fast efficient approvals Our dynamic team is empowered to make quick decisions while operating independently yet collaboratively We are always looking for original thinkers who can offer different approaches or skillsets Our curiosity drives us to dig deep into complex areas to realize our pipeline and reach our patients Ready to make a difference Apply now to join our team Date Posted 19-Mar-2025Closing Date 21-Mar-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