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.
Qualification & 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