Job Description

Job Title: Director - International CMC RACareer Level - FIntroduction to Role:
Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required for Dossier submissions and proven project management skills. You will manage complex situations to ensure correct prioritisation to deliver the needs of both the AZ business, the customer, and the future direction of CMC RA. This is an exciting opportunity to foster a positive working environment that supports continuous improvement and simplifications.Accountabilities:
As a Director, you will provide International CMC RA expertise across the business functions, lead key business improvement initiatives, and provide operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product. You will also lead knowledge sharing and provide coaching both within CMC RA and wider business functions.Essential Skills/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.Desirable Skills/Experience:
- Post graduate qualification
- Business, financial and supply chain understanding/ awareness
- Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Experience of regulatory.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. Thats why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Why AstraZeneca?
At AstraZeneca, we are working towards our aspiration to make AstraZeneca the place to build a career in Regulatory. We inspire and support to help drive your professional and personal growth and development. With a defined career ladder, a recognition culture that celebrates successes and exciting opportunities for those with the drive to achieve. Be part of the solution, turning our drug development strategies into reality. 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.Ready to make a difference? Apply today!Date Posted 31-May-2024Closing Date 06-Jun-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