Career Category

Job Description

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 Sr. Mgr. has oversight of the ADL Site CMC Team and is responsible for providing guidance and leadership to the Team, as needed.

The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.

Key Activities

Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams.

Knowledge and Skills

CMC- specific regulatory knowledge & experience

Education & Experience (Basic)

Doctorate degree and 2 years of directly related experience OR
Master’s degree and 6 years of directly related experience OR
Bachelor’s degree and 8 years of directly related experience OR
Associate’s degree and 10 years of directly related experience OR
High school diploma / GED and 12 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