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Cmc Regulatory Affairs Director
hace 2 semanas
Are you a strategically focussed Regulatory CMC professional and would like to play an integral part in bringing life changing medicines to patients? If you are please read on
**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.
**The Regulatory Affairs**CMC**Director** will provide appropriate CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and complex product ranges from development phase through to global launch and post approval lifecycle management.
This role will represent CMC in networks across the business including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, Global Quality and Operations. The role holder may lead development of new guidance, policy, and processes. They
will also be a key partner for identified customer functions to facilitate high quality partnerships within and external to AstraZeneca. The role will support and coach across CMCRA for products/projects and /or specialist areas. The Regulatory Affairs Director will have an in depth understanding in the complexity and challenges that are required for Dossier submissions and have proven project management skills.
**What**you’ll** do**
- Provide CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups.
- Provide strategic CMC RA expertise and direction for CMC submissions across the lifecycle of a product.
- Where necessary lead CMC related interactions with Health Authorities globally.
- Accountable for the provision of expert regulatory strategic guidance in support of Operational initiatives, for example complex/accelerated projects and/or post approval changes.
- Contribute to or lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca.
- Lead knowledge sharing and provide coaching both within CMC RA and wider business functions.
- Share knowledge, leading/contributing 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 CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to CMC.
- Support the implementation of agile and novel approaches in CMC Dossier Management that drive new ways of thinking to enhance efficiency and flexibility.
- Participate and /or lead due diligence teams as necessary.
- Lead /contribute to cross therapeutic non-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities / ensure management of regulatory information and ensure regulatory compliance on behalf of AZ.
- Highlight resource needs for product as appropriate for effective planning purposes.
**Education, Qualifications,**Skills** and Experience**
**Essential for the role**:
- Bachelors 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 for the role**:
- Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.
- Business, financial and supply chain understanding/ awareness
- Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
- Experience in developing products to be administered by the respiratory route.
- Experience in Line and/or matrix leadership
**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.
**So,**what’s** next?**
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you
**Competitive salary and benefits package on offer.**
**Where can I find out more?**
