Sr Associate Regulatory Affairs - CMC

Senior Associate Regulatory Affairs – CMC

What You Will Do
Facilitate product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout the product lifecycle.

Responsibilities
- Contribute as a member of the global regulatory CMC product team
- Interact with authors/reviewers and subject matter experts to deliver regulatory documents for regulatory submissions
- Organize and prepare CMC investigational product amendments, post-market supplements/variations, and new marketing applications
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide status reports for activities and projects to teams and department
- Participate in cross-functional special project teams

Basic Qualifications
- Master’s degree
OR
- Bachelor’s degree and 2 years of Pharmaceutical/Biotech/Healthcare/Med Device/Scientific experience
OR
- Associate’s degree and 6 years of Pharmaceutical/Biotech/Healthcare/Med Device/Scientific experience
OR
- High school diploma/GED and 8 years of Pharmaceutical/Biotech/Healthcare/Med Device/Scientific experience

Preferred Qualifications
- BS in life science
- Experience in manufacture, process development, QA/QC, or analytical development
- Regulatory CMC knowledge and experience
- Project management and organizational skills
- Strong oral and written communication skills

Application Instructions
- Apply at careers.amgen.com. Amgen does not have an application deadline for this position.