International Cmc Regulatory Affairs Director
hace 2 semanas
**About AstraZeneca**
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
**Chemistry, Manufacturing, and Controls (CMC)**
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
**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 Requirements**
- 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
**Why AstraZeneca?**
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
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