Job Description

Career Category Regulatory



Title (Role)

Regulatory Affairs Mgr (International CMC Regulatory)

Organization CMC, Device & Biosimilar Regulatory Affairs Team

International CMC Regulatory

Group Purpose

To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Job Summary

The RA CMC International team is responsible for generation of country specific regulatory strategies and providing feedback to the team for plans and execution of the strategy for one or more products. The RA CMC International team will interface with the Amgen affiliate offices for specific strategies or activities that impact a specific country.

Key Activities

Responsible for the development of international countries strategy and execution of the preparation of CMC components of filings for one or more products. Responsible for organization and preparation CMC marketing applications, post-market supplements, investigational product amendments and, organization and preparation CMC sections of IND annual reports and periodic notifications for specific products.

Knowledge and Skills

CMC- specific regulatory knowledge & experience

Education & Experience (Basic)

Doctorate degree
OR
Master\xe2\x80\x99s degree and 3 years of directly related experience
OR
Bachelor\xe2\x80\x99s degree and 5 years of directly related experience
OR
Associate\xe2\x80\x99s degree and10 years of directly related experience
OR
High school diploma / GED and12 years of directly related experience

Education & Experience (Preferred)

Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Regulatory CMC experience

.

Amgen