International CMC RA Director
Job Title: International CMC RA Director
Career Level - F
Introduction to Role:
Join us as an International CMC RA Director, where you will provide strategic, operational, and tactical expertise for projects and complex product ranges from development phase through to global launch and post-approval lifecycle management. This role is a unique opportunity to contribute to the creation of international CMC strategy, identifying risks and mitigations, and preparing for international markets based on the needs identified by the international business, markets, and patients.
Accountabilities:
As an International CMC RA Director, you will provide 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 be accountable for managing high-level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
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
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 health authority interactions, inspections and/or external advocacy/regulatory policy.
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's Biopharmaceuticals R&D division, 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 to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.
Join us and be supported to progress and develop fast. We are working towards our aspiration to make AstraZeneca the place to build a career in Regulatory. Here 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.
Ready to make a difference? Apply now!
AstraZeneca 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 authorisation and employment eligibility verification requirements.
