Director
Director
Posted on :
25-04-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2753651
- 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.
Employment Type
Full Time
Department / Functional Area
Key Skills
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