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
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا