Amgen Regulatory Affairs CMC Sr. Manager, Site Lead in Dublin, Ireland
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.
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
Master's degree and 6 years of directly related experience
Bachelor's degree and 8 years of directly related experience
Associate's degree and10 years of directly related experience
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