Description
Key Features -In this role, you will help support chemistry manufacturing and Control Regulatory staff performing product development and lifecycle management. Coordinate preparation of regulatory filings and amendments. Interfaces with Operations, various product teams, various site teams, regional teams and other contract services as directed. Responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. Works within Amgen systems for document management and change control management.
Skills-
- Bachelor's degree and 2 years Regulatory or Regulatory CMC experience OR
- Associate's degree and 6 years Regulatory or Regulatory CMC experience OR
- High school diploma / GED and 8 years Regulatory or Regulatory CMC experience
Preferred Qualifications
- Document management system experience
- Change control management system experience.
- Common Technical Document format experience.
- Technical writing and regulatory formatting.
- Manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry.
- Commercialization or marketing application experience.
- Strong interpersonal skills.
- Excellent communication (both written and verbal), presentation and facilitation skills.
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity.
- Strong computer skills, including word processing, database and project management software.
- Strong team player with a commitment to customer service.
To find out more about Real please visit www.realstaffing.com