International Cmc Regulatory Affairs Director
hace 2 semanas
Welcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the potential of science, then you are the perfect fit for us.
Join our Chemistry, Manufacturing, and Controls (CMC) Regulatory function, where we interpret and anticipate global Health Authority expectations to build insightful CMC and Device Regulatory Strategies. This is your chance to be part of a team that is not just about innovation but also about breaking barriers to develop better solutions.
**What you will do**
- Provide International CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups.
- Provide operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product.
- Where necessary lead CMC related interactions with Health Authoritiesfor the international markets.
- Accountable for the provision of expert regulatory strategic guidance and delivering the CMC Regulatory Submissions in support of in support new products and lifecycle management Ensure project activities managed are delivered for assigned projects to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide.
- Contribute to policy setting and strategy development in the International CMC RA environment within or external to AstraZeneca.
- Lead knowledge sharing and provide coaching both within CMC RA and wider business functions. Lead/contribute to Community of Practises across the groups or within a business unit.
- Accountable for managing high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
- Provide AZ technical functions clear, concise guidance on current International CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to International CMC.
- Support the implementation of agile and novel approaches in CMC Dossier Management that drive new ways of thinking to enhance flexibility efficiency and flexibility.
- Participate and /or lead due diligence teams as necessary.
- Contribute to cross SET non-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities / management of regulatory information and ensure regulatory compliance on behalf of AZ.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
Essential Experience:
- Degree/PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
- 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.
- Professional capabilities: Regulatory knowledge.
At AstraZeneca, we are driven by our mission to bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow and evolve. We are an integral part of bringing life-changing medicines to people. Our rich pipeline provides exposure to the complete drug delivery process and opportunities to take on new challenges.
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